Choosing Contract Research Organisations

How to Choose Contract Research Organisations (CROs) for Life Sciences Projects

Contract Research Organisations (CROs) offer pre-clinical, non-clinical, and clinical trial services, primarily serving clients in the pharmaceutical, biotechnology, and medical device industries.

CROs play an important role in research and development by providing specialised expertise, reducing costs, and enhancing efficiency compared to in-house research and development. In some cases, CROs transcend their role as mere service providers and become true collaborators with their clients.

While the benefits of using CROs for projects can be significant, there are also risks that must be carefully managed. Effective risk management begins with selecting the right CRO for your project. Below, I outline the key factors to consider when choosing a CRO.

Technical expertise

Look for a CRO that has proven expertise in your therapeutic area and stage of development.
Assess the technologies, assays, and methods they employ. Do they have advanced capabilities such as AI-driven drug discovery or specialized animal models that may be critical to your project?
Check their track record e.g., ask to see some case studies or examples of successful projects or request references.

Regulatory compliance and quality assurance

Check if the CRO adheres to relevant standards e.g., Good Laboratory Practice (GLP) (especially for preclinical safety studies, to ensure data integrity and reproducibility), Good Clinical Practice (GCP) (for projects advancing into clinical stages), Good Manufacturing Practice (GMP) (if the CRO is expected to handle manufacturing or process development).
Check if the CRO adheres to the regulations in your target market (e.g., FDA (USA), EMA (Europe), MHRA (UK)).
Preclinical regulatory knowledge e.g., can the CRO perform toxicology studies that meet regulatory guidelines, does the CRO have pharmacokinetics (PK) and pharmacodynamics (PD) expertise that meets regulatory expectations for drug metabolism and efficacy, do the CRO methods that are used to quantify drugs and metabolites in biological systems comply with the applicable validation standards?
If you are at a clinical trial preparation stage, verify the CRO’s ability to generate data packages suitable for Investigational New Drug (IND) applications in the US or Clinical Trial Applications (CTA) in Europe.
If animal studies are involved, does the CRO comply with applicable regulations and guidelines (does the CRO have any helpful accreditations)?
If cell and gene therapy is involved, does the CRO understand the specific regulatory requirements in these areas?
If genetically modified organisms or high-risk pathogens are involved, does the CRO comply with the applicable biosafety regulations for handling and studying them?
If the CRO is abroad, do they have knowledge of customs and export controls so that any biological samples or chemical compounds are transferred lawfully across borders.
Does the CRO have robust systems to handle regulatory inspections and respond effectively to queries? Can it provide comprehensive documentation and withstand audits if required?

Team and communication

Will there be a dedicated project team? A CRO with an experienced, multidisciplinary team (scientists, project managers) is ideal.
Will the CRO provide regular updates? Is there a clear escalation path for issues?

Timeline management, scalability and flexibility

Does the CRO have the resources to meet deadlines and to accommodate scaling up if required?
Is the CRO willing to adjust its approach if project parameters change or unexpected challenges arise?

Cost transparency

Does the CRO’s pricing structure align with your budget?
Do you understand the breakdown of costs and how resources are allocated?
Is there transparency on ancillary charges, such as for unexpected adjustments or additional studies?

Intellectual property (IP) protection

From the outset require robust non-disclosure agreements to protect sensitive information shared with the CRO.
Ensure that you will retain ownership of all generated data and resulting IP.
Ensure the CRO has limited, non-exclusive rights to use your background IP solely for the purposes of the project.
Include indemnity provisions where the CRO is liable for any infringement arising from their methods or tools.
If the CRO will use its proprietary tools, technologies, or methods, clearly define the licensing terms to ensure that there are no impediments to you using any resulting IP for your own purposes (including commercialisation).
Determine who will be responsible for identifying, drafting, and filing patents arising from the CRO’s work.
Require that all raw data and deliverables are transferred to you upon completion of the project and address the return or destruction of proprietary materials.
Restrict the CRO’s ability to publish or disclose results or project details without your prior written consent and define approval processes for any intended publications.
Use precise definitions and avoid ambiguous terms in the agreement to prevent future conflicts.
Most CROs will present you with their own standard terms of business/ CRO contract. Engage an IP lawyer early to review and negotiate these terms.

Geographic location

Are in-person visits important? If so, the CRO’s location will be relevant to consider.
Are you looking for specific local expertise? If so, some CROs specialise in regional regulatory environments, which can be advantageous for market-specific drugs.

Innovation and technology

Do you need cutting-edge tools and, if so, does the CRO have them (e.g., machine learning, CRISPR, advanced imaging)?
Does the CRO have potentially helpful partnerships (e.g., with academic institutions or technology firms that can offer access to novel approaches)?

Pilot projects

Consider completing a smaller pilot project to assess a CRO’s capabilities and reliability before committing to a larger collaboration.

Choosing the right CRO is a critical decision that can significantly impact the success of your life sciences project. By carefully evaluating a CRO’s technical expertise, regulatory compliance, team capabilities, cost transparency, and intellectual property protections, you can mitigate risks and set a strong foundation for your project’s success. Conducting thorough due diligence, including a pilot project if possible, ensures you select a partner that aligns with your needs and goals.

If you have questions or need support in navigating these considerations, feel free to reach out to me at m.radoycheva@mrtadvisory.co.uk. I’d be happy to assist you in making informed decisions about your CRO partnerships.

This article is a general summary and does not necessarily deal with every important topic or cover every aspect of the topics with which it deals. It is not designed to provide legal or other advice.