How to Select the Right Clinical Research Organization (CRO)

Recently I have helped several smaller organizations review and select their CRO. Choosing the right Clinical Research Organization (CRO) is a critical decision that can significantly impact the success of your clinical trial. Particularly for a smaller company, finding the right solution – both with regards to capability and culture – is critical.

Below I list some of the key areas to focus on. I doubt any of these areas area a surprise to anyone. The trick is how to evaluate these categories both within a single proposal and as well comparatively across multiple proposals (I suggest always getting at least three proposals). One needs to fully understand how the CRO is interpreting the scope of work (SOW), how they plan on executing on the SOW, and of course how they are budgeting the project. Since no two CROs do this the same, much less present it the same, it is important to utilize expertise during this evaluation and selection process.

With my years at CROs developing these proposals as well as being on the Sponsor side evaluating and selecting CROs I have a unique perspective on the process.

If you are starting this process – or even if you have already started and want another set of eyes – reach out to me.

Examples of key areas of focus during your CRO selection process:

1. Experience and Expertise
Start by evaluating the CRO’s therapeutic expertise and track record. Have they conducted trials in your indication or therapeutic area? Specialized knowledge can streamline processes and improve protocol design, patient recruitment, and regulatory compliance.

2. Regulatory Knowledge
A strong understanding of global and local regulatory requirements is vital. The CRO should demonstrate up-to-date knowledge of FDA, EMA, and ICH guidelines. Ask about their experience with regulatory submissions, audits, and inspections.

3. Technology and Infrastructure
A tech-enabled CRO can offer greater efficiency and transparency. Look for platforms that provide real-time access to trial data, remote monitoring capabilities, and advanced analytics. This allows for better decision-making and trial oversight.

4. Communication and Culture
Clear communication and cultural alignment foster a smoother working relationship. Ensure the CRO provides a dedicated project manager and has clear escalation pathways. Their team should feel like an extension of your own.

5. Flexibility and Scalability
Choose a CRO that can adapt to your project’s needs. Whether you need early-phase services or global multi-center trials, their infrastructure should scale accordingly. Flexibility in pricing models and timelines is also a plus.

6. Reputation and References
Finally, ask for client references and review case studies. A reputable CRO will be transparent about past performance and client satisfaction.