How to Choose a CRO: Top Considerations for Sponsors

Services offered and therapeutic expertise

Not every CRO is set up to handle every trial type. Ask whether they offer the exact services you plan to outsource and if they’ve executed studies in your phase and therapeutic area. While experience within the specific patient population your trial involves is often helpful, it is not always necessary – especially if, for instance, you’re working in a rare indication.

If a CRO does not have direct experience in your area of focus but feels they can still adequately support your needs, they should be able to explain how their team has supported trials with similar challenges.

Study team composition and experience

Even if a CRO’s organization experience looks solid on paper, smooth trial operations are reliant on the specific individuals assigned to a study. Consider whether the proposed team members have the expertise to anticipate common challenges in your indication and phase – but don’t stop there.

As you meet proposed team members, pay attention to how they describe cross-functional collaboration. Are they highlighting the processes that will enable them to work together throughout a study? Just as importantly, how will they integrate with your internal team? Smooth communication, clear escalation pathways, and a demonstrated ability to collaborate across functions is just as important as technical expertise.

Finally – and perhaps most importantly – be sure to dig into exactly how the team members you meet will be involved in your study to avoid any team bait-and-switch tactics. Ask plainly: in what scenarios will these proposed team leads be removed from my trial?

Subcontractor use and integration

Many CROs rely on subcontracted vendors for areas like central labs, imaging, or patient recruitment. This is not inherently a red flag – a CRO doesn’t need every service in-house to run a successful trial. What matters is how those vendors are managed and integrated. Sponsors should also note that some CROs add surcharges on top of vendor costs, so be sure to ask for transparency around pricing upfront.

It is also worth exploring the nature of the relationship a CRO has with their subcontractors. Is this a vendor the CRO has worked with repeatedly and trusts, or a newer partner? Has the CRO’s quality assurance team audited this partner, and what did that audit involve? Understanding who will oversee the vendor (e.g., the project manager, a functional lead, or perhaps another role) can clarify accountability.

Finally, depending on the nature of the service a subcontractor is providing, it may be important to ask whether these partners will participate in study kickoff meetings and cross-functional planning sessions.

Performance history and stability

Has the CRO had studies withdrawn in the last three years due to performance? If so, why? You’ll also want to look at the financial stability and longterm viability of potential CRO partners. A CRO with a shaky financial  position may cut corners on staffing or face acquisition, both of which can disrupt your trial midstream.

Don’t hesitate to ask for references or case studies that reflect how they’ve handled challenges, not just successes.

Escalation pathways and senior leadership access

Clinical trials are complex, and challenges are inevitable. While robust planning and risk management can help, studies rarely unfold exactly as expected. This is why it’s critical to choose a CRO that can quickly identify and resolve potential issues. As you speak with potential partners, ask what their escalation pathway looks like. When problems arise, do you have direct access to a director- or executive-level decision maker, or will concerns get stuck at the project team level? A CRO that empowers its team to leverage senior internal resources – and that ensures leadership team involvement when needed – demonstrates a commitment to proactive problem-solving and trial continuity.

Budget transparency and payment structures

A CRO’s proposal sets the foundation for your working relationship, and should be crafted to provide clarity. Look for:

• Detailed budgets with assumptions and pass-throughs clearly outlined.
• Transparency on vendor costs: As previously mentioned, some CROs add premiums to pass-throughs. Ask directly if vendor fees are marked up.
• Clear scope change handling: Does the proposal seem robust, and does your team have any concerns that the CRO is underbidding simply to win the work with a plan to add in changes in scope mid-study? In the case a change in scope is necessary, does the CRO have any processes in place to manage creep responsibly?
• Do the payment options offered by the CRO (e.g., milestone based, unit based, etc.) align with your internal processes? If your team requires a specific approach, include that information upfront as not all vendors will be able to accommodate.

CRO size and sponsor fit

The size of the CRO you choose can indirectly have a large impact on your experience as a sponsor. If you’re a smaller biotech company, working with a massive global CRO may leave you feeling like a small fish in a big pond, overlooked and deprioritized when resources get stretched. The key here is in finding a partner where your study can be a top priority rather than another line item.

Alignment in values and working style

Clinical trials are often quite long, which makes it especially important to partner with a CRO whose approach aligns with yours.

For example, if your team sees frequent check-ins as essential for alignment, but your CRO considers them unnecessary, friction will build quickly. Before you select a CRO, take a step back to clearly outline what matters most to you and your team. Use that insight to prioritize asking questions that matter most – whether it’s their approach to communication, decision making, collaboration, etc.

When both teams see eye to eye on how to work together, smoother trial operations can follow.

Evidence of partnership, not just service delivery

Ask whether the CRO can provide any success stories or testimonials that demonstrate acting as a cohesive extension of a sponsor’s team. Strong teams should be able to demonstrate real-world examples of collaboration, adaptability, and proactive problem-solving. Be cautious of CROs that act as “yes men” to every request – that may signal a lack of strategic input. A true partner will offer guidance when necessary to protect your study quality and outcomes.

How they support their own employees

CRO staff turnover directly affects your study. If employees aren’t supported, valued, or retained, you may end up with a constantly rotating cast of study team members rather than consistent partners. Ask about how each CRO invests in their people, from training and professional development to workload management.