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Top 17 Clinical Research Organizations (CRO) in 2023

In clinical research and treatment development, clinical research organizations (CROs) are frequently a sponsor’s most important partner and ally.

Depending on the nature of the clinical trial, and your existing capabilities as a sponsor to run the trial, the CRO company of your choice will typically be responsible for facilitating most of the micro and macro processes that go into designing and running a successful clinical trial.

When contracting a CRO to help you with your trial, you are transferring over a large portion of responsibility into the hands of your clinical research partner. The CRO of your choice will have the responsibility to control a variety of factors and processes of a clinical trial, and depending on their expertise, team structures, service offerings, internal resources and many other capabilities.

Your ability to find and contract a top CRO company that is the right fit for your unique trial will be a determinant of whether or not you will be able to operate a high-quality clinical trial that meets your expected timelines, budget and delivers a top-notch patient experience.

At ClaraHealth (a patient-centric recruitment acceleration platform) , we have put together an extensive list of the top CRO companies in the US and around the world.

This is not a cro rankings list, but rather a compiled list of some of the top clinical research organizations around the world. We have highlighted their strengths and core service offerings to make it easier for you to find the right fit clinical research partner.

In addition, we’ve put together a list of 9 fundamental questions to ask the prospective clinical research organization , which will help you to save time and ensure a right fit in picking the CRO.

Formerly known as Quintiles and IMS Health, IQVIA is one of the largest CROs in the world, with a large range of service offerings to help advance clinical research.

The company was founded in North Carolina in 1982, and has since grown to over 88,000 employees in more than 100 countries.

Some clinical trial solutions offered by IQVIA include:

• Assistance with protocol design
• Design of phase 1 clinical trials
• Assessment and improvement of phase 2 and 3 clinical trials
• Site identification & selection
• Patient recruitment
• Access to global laboratories via their wholly owned subsidiary Q2 Solutions

Parexel is a global clinical research organization that was founded in 1982, and specializes in conducting clinical studies on behalf of its pharmaceutical partners in order to accelerate and ensure the drug approval process of up-and-coming potential treatments. It currently operates in more than 50 countries, and is run by more than 18,000 employees around the world.

The company has a wide range of service offerings, covering nearly every type of clinical trial service to assist sponsors in running successful clinical studies.

Some clinical trial solutions offered by Parexel include:

• Clinical trial design and development for early phase, phase 2 & 3, and late phase clinical trials
• Clinical data management
• Decentralized clinical trials
• Clinical supply chain management
• Medical writing
• Regulatory affairs consulting
• Pharmacovigilance

3. PRA Health Sciences

PRA Health Sciences is one of the largest contract research organizations in the world. Founded in 1976 under the name “Anti-Inflammatory Drug Study Group”, the company was renamed to PRA in 1982. PRA Health Sciences employees more than 17,000 people, and provides coverage to more than 90 countries.

In 2021, PRA Health Sciences was acquired by the Ireland-headquartered global CRO leader ICON, which is also reviewed in this list.

Some clinical trial solutions offered by PRA Health Sciences include:

• Decentralized Clinical Trials Platform
• Protocol Consultation & Study Design
• Onsite Support services
• Customized Solutions for Biotech (such as asset valuation, regulatory strategy, engagement and support, drug development strategy and funding solutions)
• Clinical Diagnostics
• Site Commercial Solutions
• PRA’s Laboratories for Drug Development

Headquartered in Ireland, ICON was founded in 1990 in Dublin by co-founders John Climax and Ronan Lambre. The company has since grown to be one of the largest CROs in the world. As of September 2020, the company employs more than 15,000 people in 94 locations and across 40 countries.

ICON offers clinical research services which include consulting, clinical development and commercialization across a wide range of therapeutic areas.

In 2021, ICON acquired PRA Health Sciences, which is another CRO and global leader in clinical research services.

Some clinical trial solutions offered by ICON:

• Commercial Positioning
• Early Phase
• Functional Services Provision
• Laboratories
• Language Services
• Medical Imaging
• Real World Intelligence
• Site & Patient Solutions
• COVID-19 Clinical Operations

5. Syneos Health

Formerly known as InVentiv Health Incorporated and INC Research, Syneos Health is a publicly listed and global contract research organization. The company is based in Morrisville, North Carolina, and specializes in assisting companies with late-stage clinical trials. Syneos Health currently employs more than 25,000 people, and has offices across 91 locations.

In early 2018, INC Research was acquired inVentiv Health, and the merged company was named Syneos Health.

Some clinical trial solutions offered by Syneos Health include:

• Decentralized Clinical Trials Solutions
• Bioanalytical Solutions
• Phase II-III/Phase IIIb-IIIV
• Medical Device Diagnostics
• Clinical Data Management
• Clinical Project Management
• Clinical Monitoring
• Drug Safety & Pharmacovigilance
• Site and Patient Access

6. Labcorp Drug Development (Formerly Covance)

Formerly known as Covance and renamed to Labcorp Drug Development in early 2021, this CRO is one of the largest contract research organizations in the world. The company claims to provide the world’s largest central laboratory network, and has been rated as one of the best places to work for LGBTQ+ equality by the Human Rights Campaign organization in 2018 to 2021. Currently, Labcorp employs over 70,000 people and is able to support clinical research efforts in almost 100 countries around the world.

Some clinical trial solutions offered by Labcorp Drug Development include:

• Preclinical Services
• Clinical Trials
• Clinical Trial Laboratory Services
• Post-Marketing Solutions
• Medical Devices
• Data & Technology

Also known as Pharmaceutical Product Development, PPD is a large global contract research organization headquartered in Wilmington, North Carolina. Started as a one-person consulting firm in 1985, PPD has grown to over 27,000 employees worldwide, and provides a wide range of clinical research services to pharmaceutical and biotech companies.

Some clinical trial solutions offered by PPD include:

• Clinical Development
• Early Development
• Peri- and Post-Approval
• PPD Biotech
• PPD Laboratories
• Product Development and Consulting
• Site and Patient Centric Solutions

8. Fisher Clinical Services

Part of Thermo Fisher Scientific, Fisher Clinical Services is a global clinical research organization with headquarters in Center Valley, Philadelphia.

The company has been in the business of clinical supply chain management for over 20 years, and is focused exclusively on working with the packaging and distribution requirements of clinical trials across the globe.

Some clinical trial solutions offered by Fisher Clinical Services include:

• Biologistics Management
• Cell & Gene Therapy
• Clinical Ancillary Management
• Clinical Label Services
• Clinical Trial Packaging & Storage
• Clinical Supply Optimization Services
• Cold Chain Management & Expertise
• Direct-to-Patient
• Distribution & Logistics
• Strategic Comparator Sourcing
• Public Health Research

Established in 1997 under the name Kiecana Clinical Research, KCR is a full-service contract research organization that provides a variety of services for clinical monitoring, safety & pharmacovigilance, clinical project management, quality assurance and regulatory affairs.

KCR operates globally, and has offices in North America, Western Europe, Central Europe and Eartern Europe. The company currently employs more than 700 staff.

Some clinical trial solutions offered by KCR include:

• Trial Execution

10. Medpace

Founded in 1992 and based in Cincinnati, Ohio, Medpace is a midsize clinical contract research organization. The company has operations in over 45 countries, and employs over 2,800 people. Medpace provides support services for Phase I-IV clinical trials for pharmaceutical and biotechnology companies, which include central laboratory services and regulatory services.

Some clinical trial solutions offered by Medpace include:

• Biostatistics and Data Sciences
• Clinical Trial Management
• Drug Safety and Pharmacovigilance
• Medical Writing
• Quality Assurance
• Regulatory Affairs
• Risk-Based Monitoring
• Medpace Laboratories

11. Clintec

Now in business for over 22 years, Clintec is a medium-sized global contract research organization for pharmaceutical, biotech and medical device industries, with large expertise in oncology and rare diseases.

The company provides the flexibility and agility of a smaller-sized CRO, while also having a wide global coverage that large CRO companies are known for. Clintec is based in more than 50 countries, and was acquired by the leading global CRO IQVIA in late 2018.

Some clinical trial solutions offered by Clintec include:

• Project Management
• Data Management
• Biostatistics
• Global Feasibilities
• Patient Recruitment & Retention

12. Worldwide Clinical Trials

Bringing over 30 years of experience to the clinical research market, Worldwide Clinical Trials is a leading medium-sized global contract research organization. Founded by physicians with a dedication and commitment to advancing medical research, Worldwide Clinical Trials was the first customer-centric CRO.

Currently the company has coverage in more than 60 countries, and has extensive experience in a wide range of therapeutic areas, including central nervous system, metabolic, cardiovascular, oncology, rare diseases and general medicine.

Some clinical trial solutions offered by Worldwide Clinical Trials include:

• Bioanalytical Lab
• Early Phase Development
• Clinical Phase IIB-II Clinical Trials
• Phase IIIB-IV Clinical Trials
• Trial Management Technologies

Named #1 CRO in the world for operational excellence at the 2021 CRO Leadership Awards, CTI Clinical Trial And Consulting Services is a medium-sized global contract research organization that has been serving pharmaceutical companies since 1999.

Based in Covington, Kentucky, CTI has offices around the world in more than 60 countries, with coverage in North America, Europe, Latin America, Middle-East, Africa, and Asia-Pacific regions.

Some clinical trial solutions offered by CTI include:

• Feasibility
• Regulatory Affairs Study Start-Up
• Medical Monitoring
• Safety & Pharmacovigilance
• Clinical Services

14. Wuxi AppTec

Founded in 2000 as WuXi PharmaTech in the city of Wuxi, China, Wuxi AppTec has grown from a single laboratory into a leading global contract research organization with more than 28,000 employees, including 23,000 scientists and more than 30 research & development and manufacturing sites around the world.

With offices in Asia, U.S, Europe and the Middle East, the company is able to provide coverage to more than 30 countries around the world.

Some clinical trial solutions offered by Wuxi AppTec include:

• Small Molecule Drug R&D and Manufacturing
• Cell Therapy and Gene Therapy
• Drug R&D and Medical Device Testing
• Clinical Services (Phase I-IV)

15. Advanced Clinical

Founded in 1994 and based out of Deerfield, Illinois, Advanced Clinical is a midsize and full-service CRO that helps sponsors with running clinical trials. The company employs more than 700 staff, and offers a wide variety of services across many therapeutic areas. Advanced Clinical has global representation in over 50 countries around the world.

Some clinical trial solutions offered by Advanced Clinical include:

• eTMF & Document Management
• Global Medical Services
• Quality & Validation

16. Pharm-Olam

Pharm-Olam is a leading midsize CRO with global headquarters located in Houston, Texas and its European headquarters in Bracknell, United Kingdom. The company employs more than 800 staff, and has 25 offices around the world, with a global coverage in more than 60 countries.

The company has therapeutic expertise in 5 areas, including Rare & Orphan Disease, Infectious Disease & Vaccine, Oncology-Hematology, Allergy and Autoimmune.

Some clinical trial solutions offered by Pharm-Olam include:

• Study Feasibility
• Site Activation
• Patient Recruitment
• Medical Affairs
• Compliance & Training
• Clinical Monitoring & Operations

17. Clinipace

Founded in 2003 and based out of Morrisville, North Carolina, Clinipace is a global midsize full-service CRO with a focus on solution customization for clinical trials. The company has a large global coverage in more than 50 countries, and has offices in North America, South America, Europe and Asia-Pacific regions.

Clinipace’s therapeutic focus areas include Oncology, Nephrology and Urology, Rare Disease, Gastroenterology and Women’s Health. The company also has complete therapeutic expertise in Infectious Disease & Vaccines, Cardiology, CNS, Immunology, and Respiratory.

Some clinical trial solutions offered by Clinipace include:

• Clinical Analytics
• Clinical Technology and Ecosystem
• Functional Service Partnership (FSP)
• Regulatory & Strategic Product Development

9 Fundamental Questions To Ask A Top CRO Company Before Signing The Contract

1. which services does the cro provide.

CROs offload a lot of operational tasks from trial sponsors, which can touch any component of clinical trial operations. From formulating an overall study strategy and implementing technologies to support the operational processes of the trial, to picking and identifying sites, and supporting patients during the trial, the range of clinical services offered by a CRO tends to be vast and inclusive of all the typical services and support you will require for running a successful clinical trial.

However, not all CROs are the same in their service offerings, or are able to offer the same depth of capability within a seemingly same clinical trial support process. For this reason it is important to understand exactly which kind of clinical services and support you are looking to receive from the prospective CRO when running your clinical trial.

While services such as clinical monitoring and clinical trial management are offered by the majority of CROs, the specific needs of each trial are unique, and for this reason it is important to first identify what will be the unique services your trial requires. Completing this internal analysis first will help you to understand the extent to which a potential CRO partner will be able to provide all of these services.

Some CROs specialize in specific clinical trial functions which the company may label as a “core services”, in which case this is a sign the company will have more expertise, experience, and will be set up in a way to maximize their capabilities in providing support for these services compared to other services that the CRO offers.

For example, a CRO may include patient recruitment as part of its “core services”, which implies that they are highly skilled in and have the necessary infrastructure to design and implement a high-quality patient recruitment strategy.

Clara Health CRO Support Services: At Clara Health our specialty services include technology-augmented digital and patient advocacy recruitment, as well as patient support via our signature patient recruitment platform, which we use to upgrade clinical trials and deliver results sponsors look for in their recruitment and retention campaigns.

At Clara, we work alongside CROs to supplement and support clinical trials with modern and personalized capabilities that CROs do not typically have the bandwidth, corporate structure or infrastructure to support.

If you would like to learn more about exactly how our platform can upgrade your unique trial, feel free to book a Free 30 Minute Consultation Session Here with one of our in-house experts.

2. What Related Experience Does The CRO Have?

It is helpful to ask the prospective CRO company if they have any relevant experience in running clinical trials that would be an asset in designing and running your study. Previous experience in a related therapeutic area or in running a trial with a similar design allows CROs to have a deeper understanding into potential opportunities and challenges, increasing the likelihood of your clinical study being successful.

For example, if a sponsor is planning to run a trial in oncology, for the purpose of site identification and selection it would be valuable to partner with a CRO vendor that has expertise in this area, as they likely already have a good understanding of which sites will lead to optimal results.

However, it is also important to consider all factors when selecting a CRO vendor and not to rely on therapeutic experience as the sole qualifier for whether or not a potential CRO is a fit for your trial. While previous experience is beneficial, some sponsors close themselves off from working with vendors that have not worked in their therapeutic area, which significantly limits options when choosing a CRO partner that is truly a good fit for their clinical study.

This can impact the end result of your clinical study, as sponsors that are not successful in choosing a CRO vendor that is the right overall fit may face difficulties if the needs of their clinical study aren’t being properly met.

Clara Health: We have worked to provide support for clinical trials across a wide range of therapeutic areas and trial designs. Our specialty is filling in the gaps that CROs traditionally did not have to think about, which include digital patient recruitment, patient advocacy recruitment, and technology-augmented patient support.

Additionally, we are constantly building our proprietary data and running tests in a variety of therapeutic areas. These research efforts allow us to have a detailed understanding of the expected level of difficulty when recruiting particular patient populations, as well as allow us to predict with accuracy which segments of the targeted population will be likely to qualify in a particular study.

3. What Are The Communication Workflows & Expectations For Performing And Delivering Contracted Services?

It is important that you clarify what the expectations for communication will be between your prospective CRO vendor and your internal teams, as you will most likely be working with the CRO of your choice for the entire duration of your clinical trial.

There are a vast variety of factors and success determinants for a clinical trial, which are continuously undergoing change as the study unfolds. For this reason, it is recommended that you work with a CRO that is proactive in their communication, so that you are kept up to date with information about important changes as your clinical trial progresses.

A vendor that is proactive rather than reactive in their communication and approach to dealing with arising issues is one of the most important qualities in CRO. Challenging situations will naturally arise, and the promptness with which they are taken care of will significantly impact your clinical trial’s degree of success. Therefore, seeking a vendor that is able to match the standard of communication that you as a sponsor would like to experience throughout the duration of your partnership is one of the most critical steps in determining which CRO is the right fit for your clinical trial.

We’ve included a few additional questions pertaining to the communication structure and reporting expectations that you can ask a prospective CRO vendor to determine the degree of fit in this particular category:

Communication Expectations:

• If we were to move forward with you, which of your team members will be our main point of contact?
• How available will you be outside of the scheduled meetings to address any of our concerns or additional requests?
• What will be the frequency at which update meetings will be conducted, and who will be present at those meetings?
• Which clinical study processes will be reported on, and what will be the workflow for how we will receive this information?
• What will be the cadence at which we will receive progress reports?
• Would we be able to access metrics electronically via an interactive dashboard, or will you send us formal reports?

Clara Health: At Clara Health, we directly interact and actively work with several key stakeholders involved in running a clinical trial, which includes sponsors, CROs, sites, and patients. This unique position allows us to have a centralized perspective which helps us to see all the moving parts of a clinical trial at the same time, which helps to identify issues and relay this vital information and insight back to the sponsor (or other appropriate stakeholders) in the shortest time possible.

The ability to access this perspective allows us to gather the most accurate, complete, and up-to-date information about how the clinical trial is unfolding, and quickly becomes very valuable to sponsors for their clinical trial.

As an example, we may receive feedback from patients about having an unsatisfactory experience with a particular study site. We are able to aggregate and analyze this information, and relay our findings back to the sponsor and the study site to improve the experience for other patients.

4. What Is The CRO’s Client Satisfaction Record?

It is a good practice to request information or metrics from the prospective CRO vendor that can point to the degree of satisfaction of their past clients. Prior to signing the contract, vendors will naturally do their best to uplift their image and future value to you during their sales conversations with you and your team. It can be tricky to get an objective understanding of what the partnership experience will actually entail, especially when there are multiple vendors fighting for your commitment.

We recommend that you ask the prospective vendor to provide success metrics regarding areas of clinical trial operations that are going to be important for your trial.

For example, you may be interested in learning about the vendor’s relationship to finances, in which case it will be useful to ask them about situations in which they went over the planned budget, and investigate into the reasons behind that. Alternatively you may be concerned about potential delays in timelines, in which case it would be helpful to learn about metrics regarding the CRO’s ability to meet timeline expectations.

You may also request to talk to the prospective CRO’s past clients, which will help you to gain insight into what the relationship was like and give you the opportunity to examine if the way in which the particular CRO manages its relationships and performs its services meets the expectations that you would have for your potential relationship and for your clinical trial.

Clara Health: At Clara Health, our relationships with our partners and with our patients are most important to us. In the unique position where we fit in the clinical trial process, we have the opportunity to directly co-create the clinical trial patient experience with a variety of stakeholders, including sponsors, sites, CROs, and patients.

Our company’s values and culture have been directed and developed to be such that the client and patient experience is at the top of priority for all of our internal teams, and we work to provide the best quality of care to all stakeholders.

We have many testimonials from every type of partner we’ve worked with which we can happily share with you.

5. How Do You Adapt When Encountering Challenges With Running A Clinical Trial?

It is inevitable that challenges and unforeseen changes will arise throughout the operational clinical trial process, and for this reason it is important to work with a CRO vendor that can provide you with evidence of their flexibility and ability to adapt to sudden changes.

The ideal CRO partner is one that is highly consultative throughout the entire process, and has an ability and the initiative to deal with challenges at their seed stage, prior to them turning into major obstacles for the success of your trial.

CROs naturally have a large reach, and there are a lot of different clinical trial mechanisms and processes that are under their control. They are able to monitor and respond to what is going on in every key link in the chain of the clinical trial operation.

It is reasonable to expect this level of oversight from a CRO, and additional questions that can help you gain insight into this include:

• What are some examples where the CRO was effective at monitoring the health of clinical trials they’ve helped operate in the past?
• How quickly does the CRO respond to challenges or opportunities for improving the clinical trial experience?
• How well does the CRO gather & process information from study sites, study teams, patients & the sponsor, and what are their typical data analysis workflows?

It is also recommended to speak to the prospective CROs past clients to help you gain insight into how well they respond and adapt to the naturally arising challenges in clinical trials.

Clara Health: While CROs do have a large reach within the clinical trial, no CRO has complete visibility into every clinical process. They are not typically set up to support full visibility, which can manifest as a potential threat to your clinical trial as it unfolds. This is especially true for parts of the clinical trial processes that CROs naturally do not specialize and often subcontract, such as clinical trial recruitment.

At Clara, we are in a unique position in relation to other key partners involved in operating the clinical trial. We are in direct and frequent contact with patients, CROs, study sites, study teams, and the sponsor, and have a very deep understanding of the patient pipeline. This allows us the unique ability to go very deep into specific parts of the recruitment chain and investigate what is working and what is not working.

In addition, Clara functions as a resource for all partners in the clinical trial. For example, we work directly with site teams to ensure that they have access to a 3rd party that they can relay their needs to and receive fast support in case there is anything they require that can improve the patient recruitment process.

6. Which Parts Of Operating The Clinical Trial Will You Be Outsourcing?

Since there are so many processes and mechanisms that go into operating a clinical trial, CROs will always outsource some parts of running and managing the study. While you can expect that the prospective CRO will subcontract some of the work, it is important to find out which exact parts the clinical study will be outsourced.

There are certain basic and key clinical processes (such as site selection) that CROs almost always help with, and if you find that these parts of your trial are going to be subcontracted to another company, it is recommended to find out why the CROs operations are set up this way and how this would impact the service you will receive.

Ultimately what matters to you as a partner and client is that the quality of service and care that you will receive will be up to standard, and meet what was promised and what you are expecting. While this trust is important after you have signed the contract, it is recommended that prior to entering into such a significant commitment that you have evidence and the conviction that the CRO of your choice is truly the right fit and will deliver the quality of service that was being discussed.

Since it is impossible to predict exactly what the quality of this relationship and services performed will actually be like in practice, it is recommended that you understand the details of what will be done for your trial and how. Investigating how the CRO outsources and subcontracts services for a clinical trial will help you to gain necessary insight that you would need to make the correct vendor selection decision.

Clara Health: At Clara, we maximize the effectiveness of the digital component across the entire digital & recruitment spectrum, which is added on top of the existing capabilities of the CROs and other vendors involved in operating your clinical trial. In addition, we offer services that augment the CROs efforts, which has the potential to significantly improve the patient experience, operations flows, recruitment and retention performance, which is so important in ensuring the success of a clinical trial.

For example, if a CRO wants to have a great site relationship, we are able to come in as a third party on behalf of the sponsor and CRO and act as a resource and additional support for sites.

In another example, If a sponsor wants to have great relationships with the patient community, Clara is able to come in on behalf of the sponsor and develop these relationships while being perceived more neutrally by the patient community.

7. Do You Have Experience Running International Trials?

If you are planning on operating an international clinical trial, it is recommended to work with a CRO that has extensive experience in this area. While many CROs will offer near-global coverage, the level of experience with specific geographic locations can significantly vary from one vendor to another.

It is important to work with a CRO that has experience running clinical trials in the specific countries and regions you are planning to conduct your research in. Being compliant with the local rules and regulations for clinical testing is a very complex process that requires existing understanding and familiarity in order to ensure logistical smoothness and to mitigate legal risks. In operating a clinical trial, there are a multitude of clinical services and processes, which can greatly vary across the many regions in which you can conduct clinical testing.

A CRO that is lacking experience in operating international trials or operating in particular regions where you plan on conducting research may not be able to meet your desired quality and agility expectations, and therefore may not be the right fit for your international clinical trial.

Clara Health: In the past, we have provided international patient recruitment and digitally-augmented trial support services for clinical trials in the EU, Canada, UK, Australia and South America.

Clara Health is fully compliant to operate international studies everywhere in the world, with the exception of Russia and China.

8. What Is Your Relationship With Patients?

Patient-centric approach to designing and operating a clinical trial is becoming more and more crucial in the clinical research space. The ability of a sponsor and their CRO partner to understand the needs and characteristics of their target patient community is a significant determinant of whether or not the study will be a success.

A sponsor that has close and authentic relationships with the patient community tends to have a deeper understanding of how to create the best clinical trial experience that will attract patients and keep their interest throughout the clinical trial.

In addition, strong relationships with patients allow sponsors and CROs to forecast recruitment and patient retention pipeline with much higher accuracy. This ability is critical for ensuring the success of the trial and mitigating the risk of low enrollment. After an understanding of the patient population is acquired, sponsors gain the necessary insight to design a clinical trial that is not only favorable to their research results, but is also practical and will result in the enrollment numbers they are looking for.

While many CROs have already recognized the importance of patient-centricity and evolved the ways in which they design and operate clinical trials, other CROs have not yet made such a pivot in their values. It is important to understand the degree of importance the prospective CRO places on creating a favorable patient experience, and what kind of infrastructure the company has to support it.

At Clara, we recommend choosing a CRO partner that is adapting to the patient-centric model which is becoming more and more important for running a successful clinical trial.

Clara Health: Since early stages of our development, we’ve had a dedicated patient advocacy team that has been integral in shaping our company’s vision and operations. We have built our entire platform and recruitment infrastructure around creating the best experience for patients. Our teams, corporate values, service offerings and company infrastructure all work in the service of the patient.

In addition, over the many years of being in business we have heavily invested in building authentic patient community relationships that span across a variety of therapeutic areas. This has given us a unique ability to receive feedback directly from patients that is genuine and authentic around marketing materials, strategy for patient recruitment, and other services that we build for specific trials.

This ability to build partnerships with the patient community in an authentic way gives us a very unique ability to engage with the patient community on behalf of a pharmaceutical company, allowing our sponsor & CRO partners the opportunity to start conversations with patients through our in-house patient advocacy team.

If you would like to learn how Clara can help you to build a strong & authentic relationship with your target patient community, get in touch with us and we’d be happy to share our capabilities and previous results with you as they relate to your current or upcoming clinical trial.

9. How Is The CRO Going To Utilize Patient Input For Developing The Trial?

In the initial stages of clinical trial design, sponsors often determine the ideal patient profiles that would help them to drive the most favorable research outcomes for their study. While it is important for the success of your trial to determine who your ideal patients are, very often these projections do not match up with what is viable in practice.

At Clara, we often encounter study protocols that are not set up realistically for successful recruitment to be possible.

Common mistakes that are made when determining trial eligibility criteria and trial design include:

• Overestimating the interest in the clinical trial from the target patient population
• A lack of patient focus in the trial design
• A lack of convenience for patients in their participation
• Complicated and/or inefficient study experience flows
• Crafting the eligibility criteria around the patient population that is most likely to lead to favorable study outcomes, without conducting sufficient research to more accurately estimate the recruitment and retention difficulty of the group for a particular study

It is natural for there to be a “push & pull” between the research ideal and the real world practicality. It is important to determine the correct balance between these two sides for your trial, as going too far in either direction will decrease the chance of your clinical study’s success.

The nature of the industry as it is right now is such that there is excess research idealization and not enough emphasis on patient centricity. This distorted orientation has resulted in many clinical trials being unsuccessful, negatively impacting sponsors, patients and the entire clinical trials industry.

The ideal CRO partner should help you make sure that your protocol design sets your study up for success. The CRO should be able to help you determine the proper balance between the research ideal and the real world practicality, and back up their findings with sufficient research and patient data that can project your trial being a success.

Clara Health: When formulating a recruitment and retention plan for our clients, we begin with conducting thorough research into the target trial patient population. This allows us to get a clear understanding of which recruitment channels will yield the best results and what kind of marketing materials will resonate with the prospective study participants.

To ensure accuracy and real-world applicability of our research, we consult and collaborate with our internal patient advocacy and patient support teams, as well as with our clients and patients representing the target trial patient profiles. We then tie our findings back with any existing proprietary data that we have in connection with the therapeutic area or the prospective target patient group.

Our unique position within the clinical recruitment chain gives us the presence and deep-rooted access needed to effectively tap into any of the three patient traffic sources: digital recruitment, offline recruitment, or patient advocacy recruitment.

Once a recruitment campaign has gone live, we constantly monitor, analyze and optimize our performance to make sure that the processes we have in place are as efficient as possible and drive the greatest results. In addition, we have the capability to layer in any traditional advertising (such as billboard ads) if requested by the study sponsor.

A Career with Clinical Research Organizations in Business Development (BD)

Business development team plays an essential role in all types of industries. In pharmaceutical and clinical research industries business development teams perform many important functions suchas understanding financial aspects of running clinical studies, setting objectives and goals for the successful completion of the projects, identify and approach new clients for new business opportunities and so on.

The Clinical Business Development team specialises in bidding for and obtaining new projects from new clientsacross various therapeutic areas of interest. The team supports in employing business tactics by building and applying strategic business plans to assist sales development and key account management techniques to make sure effective conductof studies. The Business Development team may be engaged in the recruiting and developing of new sites in order to achieveorganizational growth targets. The Business Development Executive (BDE) is responsibleto achieve business development objectives set bythe organization on a monthly and yearly basis. The BDE mayalso be supporting the Site Managers / Lead Coordinators in accomplishing their patient enrollment goals via the oversight of study marketing plans and educational materials.

Education Qualification & Training Requirements for Clinical Business Development (BD) Executive Position

Bachelor / Masters Degree in life science or health care related area; MBA will be advantage for people who want to begin their career in business development.

Experience / Training Required for Clinical Business Development Executive Position

Multinational CRO’s look for people who have 2-3 years relevant experience in business development or clinical research, but there are many CRO’s who hire freshers who have health care related degree and a PG Diploma in Clinical Research and Business Development .

Job Responsibilities of Clinical Business Development Team

• Recognize and prepare clinical trial research plans with CRO’s, pharmaceutical and biotech organizations.
• Explore various pharmaceutical organization’s pipelines to find out new and up coming clinical study possibilities with a focus on obtaining new therapeutic areas, new contacts, new pharmaceutical/biotech organizations and new CROs in the industry.
• Make calls to targeted companies, seek out new contacts, finish all surveys, make follow-up calls and evaluate web sites to make sure that all possible studies are being analyzed.
• Accountable for supporting with external advertising and provide support in enrollment of subjects for ongoing clinical research at study sites.
• Recognition of new possibilities for pipeline molecules / products
• Research of all new products/ideas coming to market and evaluate business viability
• Accomplish or exceed organizational goals that have been put in placeby the organization.
• Comply with all organization procedures, instructions and directives for the achievement of organization objectives and generate sales. Maintain an automated monitoring of all ongoing leads, sales and works in process.
• Be aware to market research reports, competitive strategies/studies and convey this information to management.
• Analyse new business models, methodologies, and markets that would maximize revenue share of the organization.
• Attend yearly industry conferences to enhance Clinical Research Benefits and to obtain further data on research that can help new business opportunities.
• Support with determining and recruiting new doctors to work as researchers at trial sites.

Annual Pay Scale for Clinical Business Development (BD) Executive

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Top 15 Contract Research Organizations (CROs) in 2024

Post-pandemic, as drug development businesses recover and grow, CROs around the world continue to undergo profound transformation. As in previous years, 2023 will be all about mergers and acquisitions, with big players getting even bigger and smaller companies surviving thanks to niche advantages such as technological know-how or brilliant scientists among their employees.

The top 15 CROs globally would be in the following order based on 2023 revenue :

• LabCorp (Covance) , with 15.05 billion USD (2023) and 75000 employees ( Labcorp , 2024).  In February 2015, Labcorp completes its $6 billion purchase of Covance, Inc., creating the world’s leading health care diagnostics company. The combination of Covance’s drug development leadership and Labcorp’s medical testing expertise builds the market leader in central laboratory and bioanalysis services. Labcorp’s clinical trials companies, Labcorp Clinical Trials and Tandem Laboratories, align under the Covance brand.  
• IQVIA , with 14.85 billion USD  (2023) and 86000 employees (IQVIA, 2022). IQVIA, formerly Quintiles and IMS Health, Inc., is an American Fortune 500 and S&P 500 multinational company serving the combined industries of health information technology and clinical research.  IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. With approximately 86,000 employees, IQVIA conducts operations in more than 100 countries.  
• ICON (PRA) , with 7.74 billion USD (2022) and 41160 employees (ICON, 2023). From a small team of 5 people in 1990, ICON now employs over 41,100 people.  ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile  industry awards .  
• Thermo Fisher Scientific (PPD) , with 7.02 billion USD (2023) and 35000 employees (Businesswire, 2023). Recognized as a global industry leader in accelerating promising medicines from early development through regulatory approval and market access, we serve pharma, biotech, medical device and government organizations with custom-tailored solutions, including full-service partnerships and functional service partnerships. As a strategic partner in clinical development and analytical services, we apply cutting edge technologies, therapeutic expertise and a firm commitment to quality to help customers deliver life-changing therapies.  
• Lonza - 6.5 billion USD,   17896 employees. Though being a contract development and manufacturing organization (CDMO), rather than a CRO, takes the 10th position with the 5.9 billion USD in sales and over 17500 employees worldwide (2023), offering “proprietary line of in silico and in vitro services for manufacturability, immunogenicity, potency assessment, humanization and protein engineering” ( https://pharma.lonza.com , 2022). Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 17,500 full-time employees, it comprises high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The business benefits from global supply chains, but we have worked to maintain the agility to address marketplace needs on a local level. CDMOs become reliable partners for Pharma companies as their “services reduce R&D costs while improving productivity and are essential to providing safe and effective treatment to patients” ( https://pharma.lonza.com , 2022.  
• Wuxi AppTec with 5.8 billion USD revenue in 2021 and 44360 employees (Companiesmarketcap, 2022). As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the pharmaceutical and healthcare industry around the world to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, and cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."  

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.  

Cell and Gene Therapy CDMO Solutions has supported the development of 11 FDA approved cell and gene therapies and have conducted more than 900 studies in this field over the past year. Unsurpassed end-to-end offering results in enhanced access to scientific and regulatory expertise via multidisciplinary bench of experts to help you problem solve.   

Parexel (EQT Private Equity and Goldman Sachs Asset Management) with 3.8 billion USD in 2022 and 21000 employees (Parexel, 2023). Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere.  

• Medpace Holdings, Inc. with 1.135 billion USD revenue in 2021 and 5400 employees (Medpace, 2023). Integrating core clinical trial services delivers efficient and streamlined execution and higher quality results. Through its wholly-owned subsidiaries, Medpace offers clinical pharmacology, as well as supporting laboratory services including central labs, bioanalytical lab, ECG core lab, and imaging core labs.  

Worldwide Clinical Trials – 0.6 billion USD , 3000 employees, 60 countries.

Worldwide Clinical Trials started out more than 30 years ago as a small science team with a big goal: To always provide authentic, personalized attention to our partners. And as the industry has grown, CROs have merged, and trials have grown increasingly complex, we haven’t forgotten what truly matters: People.

With more than 3,000 employees in more than 60 countries around the world, we’re still staying true to those roots. Our team is dedicated to staying accessible, flexible, and solution-focused to ensure our partners not only have the best possible outcomes – but they also know their Worldwide team is only a call away.  

Allucent (CATO SMS and Pharm-Olam) – 0.36 billion USD, 1200+ employees .

Allucent originated with CATO SMS, itself created by the merger of Cato Research and SMS-oncology in 2019. Cato Research, founded in 1988, was known for its ability to design and execute successful development strategies and guide creative new products through the regulatory process.

Previous acquisitions by CATO SMS included Array Biostatistics, a full-service biostatistical and statistical programming CRO, and Nuventra Pharma Sciences, one of the industry’s leading providers of clinical pharmacology science and services. With these acquisitions, CATO SMS expanded its services to offer biostatistical consulting, analysis, programming, and cutting-edge modeling and simulation techniques to inform clinical trial designs and predict trial outcomes.

In early 2022, CATO SMS merged with Pharm-Olam, a global clinical research organization delivering clinical trial services to organizations around the world.  

KCR – 0.15 billion USD, 700 employees  

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations.

Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting, and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston, US, Berlin, Germany, and Warsaw, Poland.

Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people.  

Advanced Clinical – 0.1 billion USD , 1100+ employees

Today, Advanced Clinical has grown organically, with coverage across North America, Eastern Europe, Western Europe and Asia-Pacific, providing contract research organization (CRO), FSP and strategic resourcing solutions. A research services and strategic resourcing organization committed to providing a better clinical experience by delivering comprehensive Contract Research Organization (CRO), Functional Service Provider (FSP) and Strategic Resourcing services that optimize effectiveness for both patients and sponsors throughout the clinical research journey.

Using our decades of experience, we strive to improve the lives of everyone touched by clinical research and help our clients achieve better outcomes through candid conversations, foresight, resilience and innovative solutions.  

CTI Clinical Trial and Consulting Services – 0.08 billion USD, 750 employees . CTI has grown consistently and significantly, becoming a global organization with associates in more than 60 countries across the world. We have worked on more than 10,000 projects, worked on every continent except Antarctica, and have contributed to more than 150 new drug and device approvals through global regulatory agencies such as the FDA, EMA, and others. Currently, we work with approximately 250 pharmaceutical and emerging biotechnology and medical device companies.

Among recent reasons for mergers and the whole new approach to conducting clinical research, apart from pursuit of new clients, talents, expertise, products, and markets, there have been notorious coronavirus crisis and military conflicts worldwide. We faced the advent of globalization, decentralization, remote monitoring, and personalized approach to drugs R&D. But we are now looking into the era of technology in clinical research. Processes that allow remote audits and monitoring, previously considered too risky, are now risk mitigators (Bahls, Christine, 2021), at least from that point of view. Clinical trial participants enrollment, and even participation itself, constantly moves into tech dimension.

Only few among the leading CROs escaped M&As for now, but this seems to be the matter of time. Savlovschi – Wicks, Theodora (2022) estimated that “in 2021, the global CRO market is expected to reach an impressive US$88 billion by 2028”. According to IQVIA , only in biopharma sector the total transaction value grew by 70% to reach 152 billion USD by the end of 2023, featuring prominent $43Bn Pfizer-Seagen deal, and other considerable M&As for BMS-Karuna ($14Bn), Merck-Prometheus ($10.2Bn), AbbVie-Immunogen ($10.1Bn), AbbVie-Cerevel ($8.7Bn), Biogen-Reata ($7.3Bn) and Roche-Telavant ($7.1Bn).

Among the CRO businesses the following M&As took place lately:

• Charles River Labs acquires  MPI Research (2018), Citoxlab (2019), HemaCare (2020) and Cognate BioServices (2021)
• IQVIA (formerly Quintiles and IMS Health) acquired Clintec and 40% of Q2 Solutions (2021)
• ICON purchased PRA Health Services (2021)
• Thermo Fisher Scientific bought PPD (2021)
• Labcorp purchased Covance and Chiltern
• Inotiv acquired Envigo (2021)
• INC Research and inVentiv Health merged to later become Syneos Health
• Parexel become the property of EQT Private Equity and Goldman Sachs Asset Management
• CATO SMS and Pharm-Olam merged in 2022
• Triley Bidco acquired Clinigen (2022)

The article by Nataliia Vietchinkina, MS in Clinical Research Administration

University of Liverpool. 

References:

• Christine Bahls (2021) ‘The Post-Pandemic CRO Landscape’, Applied Clinical Trials, Applied Clinical Trials-09-01-2021, Volume 30, Issue 9 [online] Available from: https://www.appliedclinicaltrialsonline.com/view/the-post-pandemic-cro-landscape
• Savlovschi – Wicks, Theodora (2022) ‘Top 10 CROs to watch in 2022’ [online]. Available from: https://www.proclinical.com/blogs/2022-3/top-10-cros-to-watch-in-2022
• Labcorp (2022) Labcorp Announces 2021 Fourth Quarter and Full-Year Results, 10 February 2022 [online]. Available from” https://ir.labcorp.com/news-releases/news-release-details/labcorp-announces-2021-fourth-quarter-and-full-year-results#:~:text=Revenue%20was%20%2416.12%20billion%20%2C%20an,by%20divestitures%20of%20(0.1%25)
• IQVIA (2022) IQVIA Reports Fourth-Quarter and Full-Year 2021 Results; Raises Full-Year 2022 Profit Guidance, 15 February 2022 [online]. Available from: https://ir.iqvia.com/press-releases/press-release-details/2022/IQVIA-Reports-Fourth-Quarter-and-Full-Year-2021-Results-Raises-Full-Year-2022-Profit-Guidance/default.aspx#:~:text=Revenue%20of%20%2413%2C874%20million%20for,12.4%20percent%20at%20constant%20currency
• ICON (2022) ICON Reports Fourth Quarter and Full Year 2021 Results, 2022 [online]. Available from: https://www.iconplc.com/news-events/press-releases/icon-reports-fourth-quarter-and-full-year-2021-results/
• Businesswire (2021) ‘PPD Reports Fourth Quarter and Full Year 2020 Results’, 23 February 2021 [online]. Available from: https://www.businesswire.com/news/home/20210223006094/en/PPD-Reports-Fourth-Quarter-and-Full-Year-2020-Results
• Macrotrends (2022) ‘Syneos Health Revenue 2012-2021 | SYNH’ [online]. Available from: https://www.macrotrends.net/stocks/charts/SYNH/syneos-health/revenue
• https://companiesmarketcap.com/ (2022) ‘Revenue for Charles River Laboratories (CRL)’ [online]. Available from: https://companiesmarketcap.com/charles-river-laboratories/revenue/
• Vinluan, Frank (2021) ‘CRO Parexel changes private equity hands again, this time for $8.5B’ [online]. Available from: https://medcitynews.com/2021/07/cro-parexel-changes-private-equity-hands-again-this-time-for-8-5b/
• Medpace (2021) ‘Medpace Holdings, Inc. Reports Third Quarter 2021 Results’ [online]. Available from: https://investor.medpace.com/news-releases/news-release-details/medpace-holdings-inc-reports-third-quarter-2021-results#:~:text=The%20Company%20forecasts%202021%20revenue,%24176.0%20million%20to%20%24180.0%20million%20 .
• Companiesmarketcap (2022) ‘Revenue for WuXi AppTec (2359.HK) Revenue in 2021 (TTM)’ [online]. Available from: https://companiesmarketcap.com/wuxi-apptec/revenue/
• https://pharma.lonza.com (2022) ‘Design, assess and optimize for clinical success’ [online]. Available from: https://pharma.lonza.com/offerings/early-development-services .

Clinical Research News

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• The University of New South Wales Evolution Health Pty Ltd Not yet recruiting LaCE (Lactobacillus Paracasei LPB27 On Early Childhood Eczema) Allergy | Eczema Australia
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A Comprehensive Guide to Clinical Research Organizations (CROs)

Clinical Research Organizations (CROs) play a crucial role in the pharmaceutical, biotechnology, and medical device industries. They provide support to companies in the form of research services outsourced on a contract basis. In this comprehensive guide, we will explore what CROs are, who their clients are, the stages of the research process they are typically involved in, and delve into the exciting career opportunities within the field of clinical research.

Table of Contents

Introduction to Clinical Research Organizations (CROs)  The Role of CROs in the Research Process  Services Offered by CROs  Clients and Partners of CROs  Careers in Clinical Research  Clinical Research Associate (CRA) Roles and Responsibilities  Educational and Professional Requirements for Clinical Research  Careers Advancement Opportunities in Clinical Research  Tips for Success in Clinical Research  Careers Resources and Professional Organizations  Conclusion

Introduction to Clinical Research Organizations (CROs)

Clinical Research Organizations (CROs) are companies that provide support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. They offer a wide range of services , including biopharmaceutical development, clinical development, clinical trials management, and pharmacovigilance. CROs aim to simplify the entry into drug markets and streamline the drug development process by providing specialized expertise and resources.

The Role of CROs in the Research Process

CROs play a crucial role in the research process, from the early stages of drug discovery and development to the final stages of clinical trials and commercialization. They work closely with their clients to design and execute clinical trials, ensuring adherence to regulatory requirements and ethical standards. CROs also provide support in data management, statistical analysis, and the preparation of regulatory submissions.

Services Offered by CROs

CROs offer a wide range of services to their clients, including but not limited to: 

Biopharmaceutical development : CROs assist in the development of new drugs, from preclinical studies to early-phase clinical trials. Clinical development: CROs design and manage clinical trials, ensuring compliance with regulatory requirements and ethical standards. 

Clinical trials management: CROs oversee all aspects of clinical trials, including site selection, patient recruitment, data collection, and safety monitoring. 

Pharmacovigilance : CROs monitor the safety of drugs and medical devices during clinical trials and after they are on the market. 

Real-world evidence and outcomes research : CROs collect and analyze data from real-world sources, such as electronic health records, to generate evidence on the safety and effectiveness of drugs and medical devices. CROs conduct studies to evaluate the effectiveness and safety of drugs and medical devices in real-world settings. 

Clients and Partners of CROs

CROs work with a diverse range of clients, including pharmaceutical  companies,  biotechnology firms, medical device manufacturers, research institutions, and government organizations . They collaborate closely with their clients to ensure that research studies are conducted efficiently, safely, and in compliance with regulatory requirements. CROs also partner with academic institutions and foundations to support their research initiatives.

Careers in Clinical Research

Clinical research offers exciting career opportunities for individuals interested in the scientific, regulatory, and operational aspects of drug development. 

Careers in clinical research span a wide range of roles, including Clinical Research Associate (CRA), Clinical Project Manager, Data Manager, Biostatistician, and Medical Writer, among others. These roles require a combination of scientific knowledge, attention to detail, critical thinking, and strong communication skills.

Clinical Research Associate (CRA) Roles and Responsibilities

Clinical Research Associates (CRAs) play a crucial role in the execution and monitoring of clinical trials. Their responsibilities include site selection and initiation, monitoring study progress, ensuring compliance with protocols and regulatory requirements, and maintaining accurate and complete documentation. CRAs work closely with investigators, study coordinators, and other stakeholders to ensure that trials are conducted safely and efficiently.

Educational and Professional Requirements for Clinical Research Careers

Careers in clinical research typically require a strong educational background in life sciences or a related field. Many positions, such as CRAs, require a bachelor's or master's degree in a scientific discipline. Professional certifications, such as the Certified Clinical Research Associate (CCRA) certification, can enhance career prospects and demonstrate expertise in the field.

Advancement Opportunities in Clinical Research

Clinical research offers ample opportunities for career advancement and professional growth. Experienced professionals can progress to more senior roles, such as Clinical Project Manager or Clinical Operations Director, where they oversee the planning and execution of multiple clinical trials. Continuing education, networking, and staying updated with industry trends are essential for career advancement in clinical research.

Tips for success in seeking a Career in Clinical Research

To succeed in clinical research careers, professionals should continuously develop their scientific knowledge, stay updated with regulatory requirements, and enhance their communication and project management skills. Networking, building relationships with key stakeholders, and seeking mentorship can also contribute to career advancement in the field.

Resources and Professional Organizations for Clinical Research Professionals

Several resources and professional organizations cater to the needs of clinical research professionals. These include industry publications, online forums, conferences, and professional associations. Organizations such as the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA) provide educational resources, networking opportunities, and professional certifications for clinical research professionals.

Clinical Research Organizations (CROs) play a vital role in the pharmaceutical, biotechnology, and medical device industries by providing research services on a contract basis. They offer a wide range of services to support the development and execution of clinical trials, ensuring compliance with regulatory requirements and ethical standards. 

Careers in clinical research offer exciting opportunities for individuals interested in the scientific, regulatory, and operational aspects of drug development. By partnering with CROs and pursuing careers in clinical research, professionals can contribute to the advancement of medical science and the development of innovative therapies.

If you're interested in exploring careers opportunities in clinical research, view our current vacancies at ICON today.

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Aperio Poised for Strategic Growth; Appoints Eric Ross as Vice President of Business Development

Aperio Poised for Strategic Growth; Appoints Eric Ross as Vice President of Business Development Aperio Poised for Strategic Growth; Appoints Eric Ross as Vice President of Business Development RESEARCH TRIANGLE PARK, N.C.–(BUSINESS

CAPAssurance, a Risk Purchasing Group, Names Mitch Temple as Vice President Business Development

JULY 19, 2021

CAPAssurance, a Risk Purchasing Group, Names Mitch Temple as Vice President Business Development CAPAssurance, a Risk Purchasing Group, Names Mitch Temple as Vice President Business Development Cooperative of American Physicians, Inc.

ERS Genomics Expands Team With Appointment of Jon Kratochvil as VP Business Development

MARCH 1, 2021

ERS Genomics Expands Team With Appointment of Jon Kratochvil as VP Business Development ERS Genomics Expands Team With Appointment of Jon Kratochvil as VP Business Development Jon Kratochvil joins as Vice President for Business Development & Licensing for North America … Continue reading →

BioMarin taps Amgen, Roche vets in executive reshuffle

AUGUST 21, 2024

Greg Friberg and James Sabry will take over, respectively, as heads of R&D and business development , less than a year after BioMarin named a new CEO.

Mainz Biomed Appoints Michele Pedrocchi, Former Head of Roche Diagnostics Business Development, to Strategic Advisory Board

JANUARY 12, 2022

Mainz Biomed Appoints Michele Pedrocchi, Former Head of Roche Diagnostics Business Development , to Strategic Advisory Board Mainz Biomed Appoints Michele Pedrocchi, Former Head of Roche Diagnostics Business Development , to Strategic Advisory Board BERKELEY, Calif. and MAINZ, Germany, Jan.

Bioventus Appoints Chris Yamamoto Senior Vice President of Business Development and Strategy

NOVEMBER 16, 2020

Bioventus Appoints Chris Yamamoto Senior Vice President of Business Development and Strategy Bioventus Appoints Chris Yamamoto Senior Vice President of Business Development and Strategy DURHAM, N.C.–(BUSINESS

Metrion Biosciences appoints Nick Foster as Chief Commercial Officer and Head of Global Business Development

JULY 26, 2021

Metrion Biosciences appoints Nick Foster as Chief Commercial Officer and Head of Global Business Development Metrion Biosciences appoints Nick Foster as Chief Commercial Officer and Head of Global Business Development Appointment supports international growth within ion channel contract research and … Continue reading →

Steven C. Tomlin Named SVP of Business Development for Corizon

OCTOBER 19, 2020

Tomlin has joined the company as Senior Vice President of Business Development , effective immediately. BRENTWOOD, Tenn., 19, 2020 (GLOBE NEWSWIRE) — Corizon Health announced today that longtime corrections treatment and healthcare executive Steven C. Tomlin, who most recently served … Continue reading →

Calyxt Appoints Sarah Reiter as Vice President of Business Development

OCTOBER 14, 2020

Expanded leadership team will drive new business opportunities to support the company’s go-to-market strategies ROSEVILLE, Minn.–(BUSINESS –( BUSINESS WIRE)–Calyxt, Inc. NASDAQ: CLXT), a plant-based technology company, announced today that it has appointed Sarah Reiter as Vice President, Business Development .

PharmaJet Announces Addition of Melissa Malhame as VP Business Development

SEPTEMBER 29, 2020

.–( BUSINESS WIRE)–PharmaJet®, the maker of innovative, needle-free injection technology, today announced that Melissa Malhame, has joined the leadership team as Vice President, Business Development . Malhame is … Continue reading →

Immunovant data show potential for autoimmune disease drug

SEPTEMBER 26, 2023

Much anticipated clinical trial data for Immunovant’s experimental FcRn inhibitor could catalyze business development decisions for its parent, Roivant Sciences.

Greenwich LifeSciences Hires Industry Expert Dr. Christine Fischette to Lead Business Development & Advise on Commercialization

APRIL 19, 2021

Greenwich LifeSciences Hires Industry Expert Dr. Christine Fischette to Lead Business Development & Advise on Commercialization Greenwich LifeSciences Hires Industry Expert Dr. Christine Fischette to Lead Business Development & Advise on Commercialization Previously led partnering transactions and strategic analyses for … Continue reading (..)

MediClin AG: Business development to date shows an increasing capacity utilization in the clinics

NOVEMBER 2, 2021

Business development to date shows an increasing capacity utilization in the clinics In the first nine months of … Continue reading → DGAP-News: MediClin AG / Key word(s): Quarter Results 02.11.2021 / 13:15 The issuer is solely responsible for the content of this announcement.

Juice Pharma Introduces New EVP of Business Development

JULY 20, 2023

Experienced exec joins the agency with over three decades of driving brand growth.

Applied DNA Appoints Clay Shorrock as Chief Legal Officer and Executive Director of Business Development

APRIL 1, 2021

Applied DNA Appoints Clay Shorrock as Chief Legal Officer and Executive Director of Business Development Applied DNA Appoints Clay Shorrock as Chief Legal Officer and Executive Director of Business Development – Shorrock Rejoins Company; Appointment Underscores Company’s Pursuit of Commercial … Continue reading →

Rapid Dose Therapeutics Signs Agreement with AB Strategic Ventures for Business Development Advisory Services with First Nations Enterprises

NOVEMBER 30, 2021

Rapid Dose Therapeutics Signs Agreement with AB Strategic Ventures for Business Development Advisory Services with First Nations Enterprises Rapid Dose Therapeutics Signs Agreement with AB Strategic Ventures for Business Development Advisory Services with First Nations Enterprises BURLINGTON, Ontario–( BUSINESS WIRE)–Rapid Dose … Continue (..)

InnoCare Appoints Dr. Manish Tandon as Vice President of Business Development

OCTOBER 11, 2020

BEIJING–( BUSINESS WIRE)–InnoCare Pharma (HKEX: 09969), a clinical stage biopharmaceutical company, announced today that the Company has appointed Dr. Manish Tandon as Vice President of Business Development , reporting to the Co-founder, Chairman and CEO, Dr. Jasmine Cui.

Ontario Bioscience Innovation Organization Secures Funding for Business Development Skills Program to Support Canadian Health Science Companies

MAY 25, 2021

Ontario Bioscience Innovation Organization Secures Funding for Business Development Skills Program to Support Canadian Health Science Companies Ontario Bioscience Innovation Organization Secures Funding for Business Development Skills Program to Support Canadian Health Science Companies Innovative program will provide critical capabilities … (..)

Biocontrol and Biostimulant Industry Leader Massimo Toni joins DunhamTrimmer as Vice President of New Business Development

NOVEMBER 13, 2020

Biocontrol and Biostimulant Industry Leader Massimo Toni joins DunhamTrimmer as Vice President of New Business Development Biocontrol and Biostimulant Industry Leader Massimo Toni joins DunhamTrimmer as Vice President of New Business Development Bio intelligence leader gains 20 years experience in … Continue reading →

CytoDyn’s Chairman, CMO, and Head of Business Development Dr. Scott A. Kelly to Present at World Antiviral Congress 2021 Beginning Tomorrow

NOVEMBER 29, 2021

CytoDyn’s Chairman, CMO, and Head of Business Development Dr. Scott A. Kelly to Present at World Antiviral Congress 2021 Beginning Tomorrow CytoDyn’s Chairman, CMO, and Head of Business Development Dr. Scott A. Kelly to Present at World Antiviral Congress 2021 … Continue reading →

PAOG Confirms CBD Nutraceuticals Business Development Update To Include ALKM, USMJ and PURA Highlights Scheduled This Wednesday, June 23rd

JUNE 21, 2021

PAOG Confirms CBD Nutraceuticals Business Development Update To Include ALKM, USMJ and PURA Highlights Scheduled This Wednesday, June 23rd PAOG Confirms CBD Nutraceuticals Business Development Update To Include ALKM, USMJ and PURA Highlights Scheduled This Wednesday, June 23rd Sandusky, Ohio, … Continue reading →

Seres Therapeutics Announces David Arkowitz to Join as Executive Vice President, Chief Financial Officer and Head of Business Development

MAY 20, 2021

Seres Therapeutics Announces David Arkowitz to Join as Executive Vice President, Chief Financial Officer and Head of Business Development Seres Therapeutics Announces David Arkowitz to Join as Executive Vice President, Chief Financial Officer and Head of Business Development CAMBRIDGE, Mass.–(BUSINESS

Medexus Appoints Michael Pine as Senior Vice President of Business Development and Strategy

SEPTEMBER 25, 2020

the “Company” or “Medexus”) (TSXV: MDP, OTCQX: MEDXF), today announced the appointment of Michael Pine as Senior Vice President of Business Development and Strategy, effective September 21, 2020. MONTREAL, Sept. 25, 2020 (GLOBE NEWSWIRE) — Medexus Pharmaceuticals Inc.

Women In Bio Elects Katie Williams, Associate Director of Business Development at Applied BioMath, as 2021 President-Elect

JANUARY 7, 2021

Women In Bio Elects Katie Williams, Associate Director of Business Development at Applied BioMath, as 2021 President-Elect Women In Bio Elects Katie Williams, Associate Director of Business Development at Applied BioMath, as 2021 President-Elect Sea Island, GA, Jan. 07, 2021 … Continue reading →

M1 Kliniken AG publishes figures for the 1st half of 2021: stable business development despite continued Corona burdens

AUGUST 25, 2021

M1 Kliniken AG publishes figures for the 1st half of 2021: stable business development despite continued … Continue reading → DGAP-News: M1 Kliniken AG / Key word(s): Half Year Report/Miscellaneous 25.08.2021 / 14:30 The issuer is solely responsible for the content of this announcement.

MediClin AG: The effects of the coronavirus pandemic are burdening the business development in the first quarter of 2021

MAY 3, 2021

The effects of the coronavirus pandemic are burdening the business development in the first quarter of … Continue reading → DGAP-News: MediClin AG / Key word(s): Quarterly / Interim Statement 03.05.2021 / 17:58 The issuer is solely responsible for the content of this announcement.

How Much Business Development Should Clinical Research Sites Be Doing

MARCH 19, 2021

Every site should have a strategy for finding new studies regardless of the current number of actively enrolling studies. Established sites tend to have a larger network that can help them find new studies based on the site’s reputation.

Drägerwerk AG & Co. KGaA: Business development in the first half year significantly above prior year despite lower earnings in the second quarter

JULY 14, 2021

KGaA: Business development in the first half year significantly above prior year despite lower earnings in the second quarter 14-Jul-2021 / 19:29 CET/CEST Disclosure of … Continue reading → Drägerwerk AG & Co. KGaA / Key word(s): Half Year Results Drägerwerk AG & Co.

Business Development Is For Everyone In Clinical Research! Pharmacist Turned Entrepreneur Explains!

OCTOBER 5, 2021

Oftentimes as clinical research professionals we do not think of ourselves as sales people but expanding your opportunities in the life sciences industry is as important as anything else we will ever do for our careers.

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This is not me

What Is a CRO?

Pharmaceutical, biotechnology and medical device companies initiate, manage and fund clinical trials and are ultimately responsible for the clinical trial process. They are referred to as sponsors. Clinical trial sponsors also include government agencies, such as the National Institutes of Health (NIH) in the United States, and non-profit organizations.

The research and development process for a single drug can require the participation of thousands of people. It may take as long as 15 years to bring a new drug to market and the average cost can exceed $1 billion. It is a long, complex and expensive process, and many sponsors are not equipped, resourced or prepared to perform all trial-related duties and functions themselves.

For this reason, sponsors may choose to outsource all or part of the trial-related tasks to a company called a contract research organization (CRO) – sometimes called a clinical research organization – to manage the clinical trial on their behalf, without sponsors having to maintain a staff for these services. CROs have the capacity to conduct the day-to-day research activities that are either not possible or too expensive for a sponsor to achieve in-house. CROs are experts in the space and active partners in clinical research.

• A CRO's Role in Pharmaceutical Development
• Functions of a CRO
• Clinical Research and Trial Management
• Global and Specialized CRO Services

“It may take as long as 15 years to bring a new drug to market and the average cost can exceed $1 billion .”

CROs in the United States

the size that the global CRO market size is expected to reach, in dollars, in 2023

What is a CRO’s role in pharmaceutical development?

CROs play a major role in ensuring safe, ethical clinical trials that are essential to developing new, life-changing drugs and medical devices that benefit millions of patients worldwide .

The services that a CRO may offer can cover the full timeline of the study:

• The development and revision of protocols for trials
• The adaptation of the necessary documentation to the applicable rules
• Obtaining the necessary approvals from clinical research ethics committees and regulatory authorities
• The design and preparation of case report forms
• The determination of the sample
• The selection of the best researchers and research centers
• The final negotiation of the contracts among all parties (the CRO, vendors and sites).
• Once regulatory approval is obtained and the trial begins with site selection and patient recruitment, the CRO can provide monitoring , which consists of controlling compliance with the protocol and the procedures established for the development of the study. Likewise, pharmacovigilance services include detection and action in case of any adverse event (AE).
• The last steps to ensure the success of any clinical study are the statistical analysis and management of the trial data , the generation of reports (including the clinical study report for submission to regulatory authorities for drug approval) and the control and storage of the documentation.

CRO structure

A Contract Research Organization (CRO) acts as a bridge between the sponsor, the one who contracts the services, and the rest of the actors involved in the clinical trial.

(Leon Research, https://leonresearch.com/what-is-a-cro-and-how-can-it-help-you-in-your-clinical-trial/ )

Functions of a Contract Research Organization

Typically, a CRO provides scientific, clinical and business continuity for clinical trial sponsors. The CRO can be involved in a range of services from pre-clinical research (which takes place before human trials) to post-marketing surveillance (which takes place after a product has been approved for use).

Other administrative activities may include strategic consulting and protocol development, laboratory and analytical services, project management, trial logistics, medicine and disease coding, statistical analysis and reporting, validation programming, safety and efficacy summaries and the final study report.

Clinical research and trial management

A sponsor hires a CRO to plan, coordinate, execute and manage the life cycle of the clinical trial safely and efficiently. Serving as the main contact between the sponsor and other stakeholders throughout the trial, the CRO communicates with ethics and compliance committees, regulatory personnel, vendors, physicians and research coordinators.

Clinical trials conducted by CROs are completed on average 30 days faster than those conducted by sponsor companies. 1

Every day counts for both patients (who may be anxiously waiting on therapies that could improve or even save their lives) and sponsors (because time spent in the development process counts against the patent protection period after the drug goes to market, affecting sales revenue).

35 years of experience

With more than 35 years of experience, the PPD™ clinical research business of Thermo Fisher Scientific offers an established drug development platform, patient enrollment expertise and robust laboratory services . Our broad range of clinical development, analytical and patient and advisory services – including full service to functional service provider services , digital and decentralized trials, and laboratories – enables customers to drive innovation and increase drug development productivity. We are recognized for accelerating promising medicines from early development through regulatory approval and market access. Our flexible, custom-tailored solutions serve pharmaceutical, biotech, medical device, academic, government and public health organizations in clinical research and development .

Global and specialized CRO services

Most large CROs are full-service, providing complete clinical trial management support, but there are some companies specializing in a specific type of study (e.g., research with medical devices or observational studies) and also CROs specializing in a specific therapeutic area, such as oncology or ophthalmology.

Global CROs, large companies with operations all over the world, provide greater, integrated geographical coverage, with more service offerings and capabilities, while local companies may sometimes have more in-depth knowledge of a particular country’s nuances and demographics as they relate to clinical development.

Global network

The global network consisting of clinical sites within the PPD™ clinical research business of Thermo Fisher Scientific and non-owned partner sites offers access to a diverse pool of healthy volunteers and specialty populations around the world. Our experienced staff provides external oversight of a trial, working directly with the institutions where clinical studies are conducted – hospitals and clinics, called investigational sites. We provide training to the principal investigator and the site staff, and ensure that the safety, rights and well-being of patients are protected; that the conduct of the trial is in compliance with regulatory requirements; and that reported trial data are accurate and complete.

What is the difference between a CRO and a sponsor?

Although the sponsoring company may transfer the trial functions to a CRO, the sponsor owns the investigational product and needs to ensure results are factual and scientifically backed. 

According to the definition of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) , a CRO is: “A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.” 

The sponsor maintains a central role throughout the clinical trial process. Although regulatory tasks differ globally, they include initiating the trial process by submitting an application and ensuring approval is obtained (directly or indirectly).

The ICH Guideline for GCP specifies the responsibilities a CRO can take over from a sponsor : 

• 5.2.1: A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
• 5.2.2: Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).
• 5.2.3: Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
• 5.2.4: All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.

What are the advantages of outsourcing to a CRO?

A CRO can offer substantial cost savings for a sponsor by reducing the time it takes to conduct a trial compared to a sponsor doing so in-house. This also eliminates the need for staff, infrastructure and lab and office space for the sponsor to run the trials themselves. Finally, a full-service CRO can provide access to a global network of clinical research sites, meaning it can quickly identify suitable sites for clinical trials in multiple countries. Geographical reach or therapeutic focus can be important in patient recruitment, especially in specific populations, such as underserved and diverse , or for rare diseases that affect a small subset of people.

Working with a CRO gives sponsors access to the most advanced technology and systems for data management, product development, research analysis and other clinical research services. CROs are quick to adopt the latest technologies, enabling them to provide strategic insights and advice, and to offer novel and distinctive ways to use advanced tools and adapt them to each sponsor’s needs to ensure optimal clinical trial performance. Given that CROs work with many different sponsors, they often have a breadth of experience beyond even a single large pharmaceutical company.

CROs adhere to clinical compliance on a daily basis, which requires intricate in-house knowledge of regulatory requirements and audits such as GCP (Good Clinical Practice) or GLP (Good Laboratory Practice) audits.

Sponsors conducting clinical research in a niche area such as rare disease may choose to work with a specialty CRO or a global CRO with offering such services.

We have an extensive global network of investigators, clinicians and partners with a wide range of products, technologies and services that can be leveraged for clinical trial conduct. Our goal is to deliver considerable time and cost savings in drug development, critical to accelerating the delivery of life-changing therapies. Our experts consider the end before the beginning by envisioning and planning for commercialization and market acceptance well before the first patient is enrolled in a clinical trial. And before trials are underway, we design for post-approval, real-world patient observation that provides support for payer authorizations and may lead to new  ideas and products .

How does a sponsor select a CRO?

When selecting a CRO, here are some questions to consider:

• Can the CRO offer the services that the sponsor needs?
• Does the CRO have related experience and a good track record (i.e., similar projects and references or testimonials from satisfied clients)?
• Is the CRO financially stable?
• Does the CRO have a good system for employee training and a low staff turnover rate?
• Does the CRO have the key staff members required and can it set up a team to deliver qualified results?
• Does the CRO have the required infrastructure?
• Does the CRO have a robust quality assurance system?
• Is the CRO’s team responsive and willing to work with you and communicate throughout the project?
• Does the CRO have specialty services, laboratories, digital and decentralized solutions, a clinical supplies network and other capabilities important to your drug development program?
• Will the CRO help you recruit and manage safety boards or committees?
• Will the CRO conduct audits to help you prepare to pass FDA inspections?
• Can the CRO provide general site support and project management help in addition to clinical monitoring?
• Does the CRO function as a vendor or a true partner ?

Drive your drug development program forward

Partner with a leading, global provider of CRO solutions that leverages a proven track record and deep expertise to keep the patient at the forefront of your trial.

The PPD clinical research business of Thermo Fisher Scientific accelerates your success with a dynamic, forward-thinking approach, a comprehensive suite of capabilities and true partnership with our customers.

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The clinical trial business development lifecycle.

Webinar Date: February 17, 2020

Webinar Guests: Mark Ragusa, former Director of Research at Raleigh Neurology Associates

Don’t do clinical trial business development haphazardly. Mark Ragusa, former Director of Research at Raleigh Neurology, shares his framework for systematically targeting and nurturing your sponsor and CRO relationships to create a rich, site-appropriate study pipeline. Raleigh Neurology is one of the leading go-to sites in the space. Learn how Mark identifies sponsors, adjusts his site’s value proposition, and maintains a regular cadence of communication. This high-touch, disciplined process can be your key to growth.

21 CFR Part 11 Regulation Compliance Update

Compliance Update:  The 21 CFR Part 11 Regulation is a cornerstone of conducting clinical trials in today’s world.  The release of the regulation 1997 established guidelines for the use of electronic records and electronic signatures in FDA-regulated industries and had a significant impact on the pharmaceutical and medical device industries. The FDA began working on...

The Current State of Clinical Trials in Ukraine—A Conversation with Dr. Roman Fishchuk

Meet Dr. Roman Fishchuk, an esteemed otorhinolaryngologist (ENT) whose journey in the healthcare field has been marked by a commitment to providing medical care and innovative treatment options through clinical trials in his native Ukraine. Having graduated from Ivano-Frankivsk National Medical University, Dr. Fishchuk specialized in otolaryngology and completed a Master’s degree at the University...

Transitioning to CRIO? How to Get Your Data Ready for Migration

You have just signed on to use CRIO and you are excited to get started. Even if you are moving primarily from paper, you may have data that you want to migrate into CRIO rather than having to re-enter it. For many of our new clients, they have a wealth of information available in spreadsheets...

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Parexel Biotech provides the end-to-end capabilities you’ll need to succeed. We're fast, flexible, and dedicated to impacting patient lives.

Utilize our expertise across therapeutic areas, combining innovative trial designs, leading clinical and regulatory expertise, global reach, and a passion for changing patient lives.

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Our experts help you stay at the forefront of the industry - and ahead of change.

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New Medicines, Novel Insights: Advancing precision oncology

Thinking about joining a clinical trial? Learn the drug development process, what it’s like to participate, how to find a trial, and answers to frequently asked questions.

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The perspectives and opinions expressed in this material represent those of the patient advocate only and should not be considered a solicitation, promotion or advertisement for any services of Parexel, or any drugs or therapies, including those under development. Participating in clinical trials for investigational medicines offers patients potential benefits, such as access to cutting-edge treatments and expert medical care, while contributing to medical research. However, risks may include side effects, unpredictable outcomes, and time commitment. Careful assessment of these factors helps patients make informed decisions. The content of this material, including graphics, images and text, is provided for informational purposes only and does not constitute medical advice, diagnosis or treatment. Please consult your healthcare professional for medical advice. The patient advocate has provided their consent for the use and distribution of this content.

Patient Story

• Inflammation & Immunology

Rare Diseases

• Cell & Gene Therapy

Tina had lost her father to Crohn's disease. Now she faced her own diagnosis.

Then came the diagnosis. Finding out she had Crohn’s disease, one of two IBD syndromes that affect 10 million people worldwide, wasn’t a surprise considering her family’s history with the disease. But it derailed her life.

Tina was in her early 20s. She lived in New York City and was building a promising future for herself in finance.

She spent the next 10 years trying countless medications and underwent 20 surgeries. nothing worked., then, finally, she enrolled in a clinical trial., within months, she was in remission—and has been ever since., today, she’s a patient advocate, sharing her experiences to help keep our clinical trials focused on the needs of patients like her., lives can change when you design inflammation and immunology trials with agility, precision, and care..

• Keep up with urgent clinical demands
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What we do, we do

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MORE EXPERTS

Bharti Arya

Executive Director, ...

Michelle Pietzak, M.D.

Global TA Section He...

Mwango Kashoki, M.D., M.P.H.

Senior Vice President, Global Head of Regulatory Strategy

Mwango brings over 20 years of clinical and regulatory drug development experience to her role at Parexel, including more than 16 years at the U.S. Food and Drug Administration (FDA).  She provides strategic and technical guidance on various regulatory and clinical aspects of drug development, leveraging her expertise in clinical review, pharmacovigilance and post-approval safety requirements across multiple therapeutic areas.  Mwango is a critical asset for our customers, helping them navigate the changing regulatory environment on their development journeys to deliver important new treatments to patients in need across the globe.

Our I&I team is 13,100+ strong, with experience across indications, to match the needs of your trial.

Our diverse project experiences and expertise in patient recruitment and engagement result in fast, efficient trials.

Clinical trial sites around the world allow us to accelerate study startups.

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Innovative trial designs allow us to optimize your trials for maximum impact.

And our patient-first approach results in deeper, more relevant insights for trial design and execution.

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Clinical Research Organizations

• First Online: 19 November 2022

Cite this chapter

• Gregory A. Hale 6 &
• Jennifer Pullum 7  

Part of the book series: Pediatric Oncology ((PEDIATRICO))

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Contract research organizations, also known as clinical research organizations (CROs) or contract service organizations (CSO), or pharmaceutical development organizations, are established businesses that collaborate with pharmaceutical or medical device companies to assist them in the clinical development of their medication or device. While the sponsor retains responsibility for the conduct of the trial, CROs provide essential support services that may include regulatory affairs, regulatory submissions, budget generation, data management, biostatistics, medical monitoring, clinical monitoring, medical writing, and project management. CROs facilitate drug and medical device development by operationalizing clinical trials in accordance with Good Clinical Practice (GCP) guidelines, relying on their expertise in clinical trial conduct, operations experience, and close relationships with sites and investigators.

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Contract Research and Investigator Driven Research

Functions and Types of Contract Support Organizations (Including CROs, CMDOs, Packagers, and Contract Formulators)

Contract Research Organizations

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Hale, G.A., Pullum, J. (2022). Clinical Research Organizations. In: DiMartino, J., Reaman, G.H., Smith, F.O. (eds) Pediatric Cancer Therapeutics Development. Pediatric Oncology. Springer, Cham. https://doi.org/10.1007/978-3-031-06357-2_8

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GLOBAL CHALLENGES IN CLINICAL TRIALS

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Almost $2B spent on underperforming sites in 4 years by global pharma community

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Labcorp to spin off clinical development business

Clinical Development Business to be a Leading, Pure-Play Contract Research Organization with a Comprehensive Set of Clinical Trial Management, Market Access and Technology Capabilities

Labcorp Remains a Leader in the Laboratory Market with Highly Complementary, Laboratory-Focused Businesses including Routine and Esoteric Labs , Central Labs and Early Development Research Labs

Transaction Designed to Create Value Through Enhanced Strategic and Operational Focus

Labcorp to Discuss Spin-off and Second Quarter 2022 Financial Results at 9:00 a.m. ET Today

BURLINGTON, N.C. --(BUSINESS WIRE)--Jul. 28, 2022-- Labcorp (NYSE: LH) (the “Company”), a leading global life sciences company, today announced that its Board of Directors has authorized the Company to pursue a spin-off of the Company’s wholly owned Clinical Development business to Labcorp shareholders through a tax-free transaction. The planned spin-off will result in two independent, publicly traded companies, each poised for strong, sustainable growth:

• Labcorp : A leading global laboratory business comprising the Company’s routine and esoteric labs, central labs and early development research labs, all of which are leaders with deep scientific expertise, vast health data and insights, and an extensive, advanced global laboratory network.
• The Clinical Development Business: A leading, global Contract Research Organization (CRO) providing Phase I-IV clinical trial management, market access and technology solutions to pharmaceutical and biotechnology organizations.

Following the decision by the Board last year to initiate a dividend and accelerate the Company’s share repurchase program, Labcorp’s management team and Board continued to evaluate all avenues to further enhance stakeholder value. The planned spin-off is expected to provide each company with:

• Strengthened strategic flexibility and operational focus to pursue specific market opportunities and better meet customer needs.
• Focused capital structures and capital allocation strategies to drive innovation and growth.
• A more targeted investment opportunity for different investor bases. 

Adam Schechter , chairman and CEO of Labcorp . “Our shareholders will be able to participate in the upside potential of two market-leading businesses in the global healthcare sector, each of which will be well-capitalized and positioned to generate sustainable growth with strong free cash flows and attractive returns. Our customers will continue to have access to our full range of capabilities with the same quality and seamless delivery of services they have come to expect from our teams. Today is a testament to our long history of growth through innovation and track record of delivering on our mission to improve health and improve lives.”

Labcorp : A Compelling Value Proposition with a Strong Growth Platform Serving All Healthcare Sectors and Customers

Labcorp will remain a global leader advancing healthcare through science, innovation and technology with deep scientific expertise, vast health data and insights, and an extensive, advanced global laboratory network. Together, its lab-based businesses will create a cohesive, global provider of laboratory-focused services with complementary resources operating at scale and a diverse customer base. Following the planned spin-off, the business will be positioned to:

• Invest in R&D and innovation to develop and launch diagnostic advancements globally in key areas including oncology, Alzheimer's, autoimmune and liver disease through organic and inorganic opportunities.
• Bring together its global health and patient data and provide insights to enable customers to advance innovation.
• Utilize its worldwide laboratory network to serve a broad, growing and global customer base including pharmaceutical and biotechnology companies, physicians, health systems, consumers, and other start-ups and labs who require lab services or diagnostic testing.
• Launch innovative tests globally, providing patients, physicians, health systems and pharmaceutical companies with access to Labcorp’s advanced science, technology and diagnostic capabilities.

Over the last four quarters ending June 30, 2022 , Labcorp’s routine and esoteric labs, central lab and early development research lab businesses delivered total revenue of $12.7 billion , or $10.5 billion excluding COVID-19 Testing revenues. These businesses combined grew 5.5% on a CAGR basis from second quarter 2019 to second quarter 2022 excluding COVID-19 Testing revenues. Going forward, Labcorp will continue to have an attractive growth profile and is expected to deliver mid-single digit annual revenue growth. In addition, Labcorp remains committed to its capital allocation strategy and maintaining its investment grade credit rating.

Adam Schechter will continue to lead Labcorp as chairman and CEO following the completion of the planned spin-off. Labcorp will continue to be headquartered in Burlington, North Carolina .

The Clinical Development Business: Leading Global CRO Focused on Supporting Biotechnology and Pharmaceutical Customers and Accelerating Innovation

The Clinical Development business will continue to be a leading global provider of Phase I-IV clinical trial, market access and technology solutions to both large and emerging pharmaceutical and biotechnology organizations. Following the planned spin-off, the business will be positioned to:

• Capitalize on growth opportunities across Phases I-IV clinical trials and extend its leadership in oncology, cell and gene therapy, rare disease, and other emerging therapeutic areas.
• Increase agility with large pharmaceutical and biotechnology clients to better serve customers and advance life-saving therapies.
• Retain access to Labcorp’s vast health and clinical data set through an arrangement which will enable it to provide enhanced trial execution and a differentiated value proposition.
• Continue to invest in capabilities, technologies, diverse talent and innovation to enhance trial execution and better serve all of its customers.
• Implement a capital structure that is tailored to support its growth strategy and enhance stakeholder value.

Over the last four quarters ending June 30, 2022 , the Clinical Development business delivered total revenue of $3.0 billion . This business grew 8.0% on a CAGR basis from second quarter 2019 to second quarter 2022. Going forward, the Clinical Development business is expected to deliver high-single-digit revenue growth.

Transaction Details

Labcorp currently expects to effect the planned spin-off through a dividend of the Clinical Development business’ shares to Labcorp’s shareholders. Following the spin-off, Labcorp expects to continue to be publicly traded on the New York Stock Exchange and expects the Clinical Development business to be publicly listed. The spin-off is intended to qualify as a tax-free transaction for U.S. federal income tax purposes.

The Board of Directors, executive leadership, and company name of the Clinical Development business will be determined and announced in the future as plans for the spin-off continue to progress.

Labcorp anticipates that, consistent with any applicable legal and tax requirements, there will be ongoing transitional and commercial arrangements to provide for a seamless delivery of services to the customers and other stakeholders of the Labcorp and the Clinical Development businesses.

Labcorp is targeting completion of the planned spin-off in the second half of 2023. The spin-off will be subject to the satisfaction of certain customary conditions, including, among others, the receipt of final approval by Labcorp’s Board of Directors, the receipt of appropriate assurances regarding the tax-free nature of the separation and effectiveness of any required filings with the Securities and Exchange Commission . Labcorp notes that there can be no assurances regarding the ultimate timing of the transaction or that the spin-off will be completed.

Barclays, Evercore and Goldman Sachs & Co. LLC are serving as Labcorp’s financial advisor, and Jones Day and Hogan Lovells are serving as legal counsel.

Conference Call and Webcast

Labcorp will discuss the spin-off announcement on its second quarter 2022 earnings conference call, which will be held today at 9:00 a.m. ET . The online webcast of the call, along with the accompanying slide presentation, will be available at http://www.labcorp.com.

The conference call may also be accessed by dialing 800-715-9871 (646-307-1963 for international callers). The conference ID is 4124787. A telephone replay of the call will be available through August 11, 2022 , and can be heard by dialing 800-770-2030 (609-800-9909 for international callers). The conference ID for the replay is 4124787.

About Labcorp

Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With over 75,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $16 billion in FY2021. Learn more about us at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp .

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements, including but not limited to statements with respect to the proposed spin-off of the Clinical Development business (“CD”), including statements regarding the expectation that the transaction will be consummated, the anticipated timing of the transaction, benefits of the transaction, the expected tax treatment of the transaction and opportunities for future growth.

Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond Labcorp’s control, including without limitation: (i) uncertainties as to the completion and timing of the transaction; (ii) the failure to obtain appropriate assurances regarding the tax-free nature of the spin-off; (iii) the receipt of regulatory approvals; (iv) the effect of the announcement or pendency of the transaction on Labcorp’s business relationships, operating results, and business generally; (v) unexpected issues that arise in the continued planning for the transaction; (vi) the failure to have the Form 10 registration statement that will be filed with the SEC declared effective on a timely basis, or at all; (vii) risks that the proposed transaction disrupts current plans and operations of Labcorp or CD; (viii) potential difficulties as a result of the transaction with Labcorp or CD employee retention; (ix) risks related to diverting management’s attention from Labcorp and CD’s ongoing business operations; (x) the ability of Labcorp to successfully separate CD operations from Labcorp’s ongoing operations; (xi) market receptiveness to effect transactions in the capital markets; (xii) market reaction to the announcement and planning for the transaction; and (xiii) other risks that relate more generally to ongoing business operations, including the trading price of Labcorp’s stock, competitive actions and other unforeseen changes and general uncertainties in the marketplace, changes in government regulations, including healthcare reform, customer purchasing decisions, including changes in payer regulations or policies, other adverse actions of governmental and third-party payers, changes in testing guidelines or recommendations, federal, state, and local government responses to the COVID-19 pandemic, the impact of global geopolitical events, the effect of public opinion on the company’s reputation, adverse results in material litigation matters, the impact of changes in tax laws and regulations, failure to maintain or develop customer relationships, the company's ability to develop or acquire new products and adapt to technological changes, failure in information technology, systems or data security, the impact of potential losses under repurchase agreements, adverse weather conditions, the number of revenue days in a financial period, employee relations, personnel costs, inflation, and the effect of exchange rate fluctuations. These factors, in some cases, have affected and in the future (together with other factors) could affect Labcorp’s ability to implement its business strategy, including the proposed spin-off, and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of the forward-looking statements.

Labcorp has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in Labcorp’s most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in Labcorp’s other filings with the SEC . The information in this press release should be read in conjunction with a review of Labcorp’s filings with the SEC including the information in Labcorp’s most recent Annual Report on Form 10-K, and subsequent Forms 10-Q, under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

View source version on businesswire.com : https://www.businesswire.com/news/home/20220727006194/en/

Chas Cook — 336-436-5076 [email protected]

Christopher Allman-Bradshaw — 336-436-8263 [email protected]

Source: Labcorp

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The Department of Business Development is Mayo Clinic’s front door to business – from technology commercialization to strategic partnerships – catalyzing innovation to shape the future of healthcare for the benefit of patients.

Our  Mayo Clinic Ventures  and  Corporate Development  teams come together as one unified force to bridge the gaps between industry and commercial groups to produce meaningful, effective changes in transforming health and medicine.

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Our mission is to aid pharmaceutical and biotech companies with the delivery of new drugs and medical products to patients in the shortest time possible. We take pride in the utmost quality of service, transparency of operations, and full commitment to improving the lives of people around the world.

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The Yale Center for Clinical Investigation (YCCI), in collaboration with our Yale Cultural Ambassadors, is offering a voluntary summer research internship, that provides the opportunity for highly motivated high school, undergraduate, and professional students to work with and learn from a multidisciplinary team of scientists, including internationally renowned investigators. Interns in the Exposures program work and learn remotely. The primary aim of our internship program is to train and prepare youth with diverse backgrounds and interests to become future leaders in the realm of clinical and translational research.

YCCI Exposures Program/ Virtual Student Research Internship Summary

In the summer of 2021, the Yale Cultural Ambassadors asked YCCI to consider the development of a summer internship program for high school students age 15 and older and undergraduate students that would spur an interest in healthcare, medicine, and clinical and translational research at a young age. The center received Yale approval for the YCCI Clinical and Translational Research Exposures Summer Internship Program, a four-week virtual educational experience focused on the areas of technology, mobile apps, patient engagement, disparities, and data science in health care.

During the first three years there were 96 motivated interns selected from a pool of over 1500+ applicants. These young scholars were from 22 different states, Canada, Mexico, Puerto Rico, and Kazakhstan and for many of the students this was their first internship experience. YCCI leadership continues to work with its community partners to engage young scholars, age 15-21 to be a part of this program.

The internship has provided the opportunity for this group of highly motivated students to work with and learn from a multidisciplinary team of scientists, including internationally renowned investigators and leaders. The program included course work, lectures, journal club, a group project, and virtual lunches with clinical and research leaders.

Internship Objectives

• Gain knowledge of and exposure to current topics in clinical and translational science, including the basis for common and complex traits and diseases in humans, as well as the integration of mobile technologies to monitor and improve health care.
• Learn more about technology, mobile apps, patient engagement, disparities, and data science within health care.

Based on the intern’s individual interests, he or she will be assigned a primary mentor. It is the mentor’s responsibility to advise and guide the intern with respect to achieving the aims and requirements of the program. The mentor will also provide information and insights regarding career options in health care and clinical research. Although each intern will work primarily with his/her individual mentor, they will meet and interact with other leaders and interns within YCCI. At the end of the internship, each participant will present their final project to a group of institutional and community leaders.

Internship Requirements

• Seminar Attendance : Interns will attend weekly seminars and prepare for these seminars accordingly (e.g., read assigned journal articles). They will participate in Clinical Research Brown Bag Roundtable Lunch with Faculty, Clinical Research Journal Club, and Clinical Research Meeting.
• Research Proposal : Interns, together with their mentors, will each develop an independent research project or participate in a group project to be completed by the end of the internship.
• Presentation of Research Project : Present results of the independent/group research project during the second half of the internship period at a virtual YCCI Research Meeting, which may include Yale and community leaders and intern’s family/guest. If appropriate, interns may submit abstracts for presentation at a scientific meeting mutually agreed upon by the intern, his/her mentor, and a senior faculty member.

Who Can Apply

Highly motivated students in high school or college may apply. The primary criterion for admission is an interest to learn more about careers in clinical research or health care.

Please note that high school students must be at least 15 years of age before the start of their internship.

Selection Process

• Candidates will be selected based on enthusiasm and desire to learn more about health care and clinical research.
• After all applications are reviewed, elected applicants will be notified of program acceptance.
• Interns will receive a certificate of completion. Interns may also receive school credit or transcript notation for participation in our summer research internship. Please check with your guidance counselor or department dean about whether this will be possible.

Related Documents

• Exposures Participant Form – over 18
• Exposures Participant Form – parent/guardian permission under 18
• Exposures Program Rules – over 18
• Exposures Program Rules – parent/guardian permission under 18

Important Dates

Internship Dates July 8 - August 1, 2024

Hours The internship hours will be 10AM – 2PM, Monday – Thursday

Application Deadline April 19, 2024

Please note: During the summer of 2024 program, all interns will be trained and will work and learn remotely

Meet Our Summer Interns

Organizations on this page, 2021 summer exposures interns, 2022 summer exposures interns, 2023 summer exposures interns.

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About the CRCO

The Clinical Research Compliance Office (CRCO) is a unit of the Office of the Vice Chancellor for Research committed to partnering with the research community to promote innovation and effectiveness while upholding a strong compliance program. The CRCO aligns with UNC-Chapel Hill’s mission to advance scientific knowledge and protect the rights, safety, and well-being of research participants locally, nationally, and internationally. We achieve this by:

• Supporting Sponsor-Investigators throughout the lifecycle of drug, device, and biologics development.
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• Supporting the clinical research community with comprehensive compliance education and resources.
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