Insights From an Expert: Written by Richard Polgar, Managing Director, Danforth Advisors
One common question biotech leaders consistently ask is, “Who’s the right CRO for our trial?” After 25 years of experience across CROs, pharma, and consulting for biotech companies, I’ve learned the question itself often misses the mark. The real focus should be on understanding your specific needs and capabilities, focusing on CRO selection strategy, rather than searching for the perfect CRO.
What One Biotech Got Right (and Wrong)
Recently, I guided a sponsor through awarding a significant Phase III trial. Immediately after signing, the CRO unexpectedly reassigned the Director and both project managers. Although pulling the contract was tempting, maintaining the relationship proved crucial. The CRO stepped up, addressed the personnel changes openly, and preserved trust. The lesson here on CRO selection strategies is clear: teams change frequently, and your success hinges on adept change management, not the perfection of initial organizational charts.
Exploring Full Study Outsourcing vs. Functional Service Provider Models
How you utilize your resources often outweighs which CRO you select. There are two primary models—Full Study Outsourcing (FSO) and Functional Service Provider (FSP)—each with distinct advantages and challenges. When designing your CRO partnership, your choice of model matters.
In an FSO model, a single CRO manages the entire spectrum of clinical tasks, from initial protocol development to final Clinical Study Report. Variations exist, such as hybrid arrangements that utilize FSO through database lock and alternative solutions for biostatistics and medical writing, or expanded responsibilities that bundle third-party services like labs and imaging.
Conversely, FSP models typically involve hourly or monthly fee-based resource contracts, ideal when substantial volumes of work are available. However, a small sponsor with only one trial might not benefit from an FSP setup, which essentially becomes simple staff augmentation without broader strategic benefits. Effective use of FSP demands careful consideration of how resources shift as trials conclude.
Strategic planning also applies to FSO when managing a portfolio rather than a single study. Designing a flexible, long-term, programmatic solution that offers similar protections as FSPs, like cost-shifting and scalability, requires extensive planning. Few sponsors dedicate sufficient time to develop such strategic foresight.
Regardless of model, the best CRO selection strategy considers not just present needs, but how your study might evolve.
The Context Matters: Case Study of a Rare Disease Trial
Another sponsor selected a global CRO simply because they had previously collaborated successfully at a larger pharma company. However, their current context differed drastically: limited internal bandwidth, modest site payments, and only a protocol synopsis. The outcome was predictably challenging. Selecting a CRO based solely on past affiliations ignores current realities and risks failure. Your CRO selection strategy should reflect current bandwidth, budget, and phase-specific needs.
CRO Selection Strategy: Size and Specialization of CROs
In CRO selection strategy, you must keep in mind that different CRO sizes and specializations yield different benefits. Small biotechs often benefit significantly from FSO models due to reduced overhead and increased accountability. However, large CROs, despite potential issues with client visibility, often offer superior tools, processes, and marketing visibility.
Large CROs frequently experience higher turnover rates, yet many companies repeatedly select them due to familiarity and perceived safety—the “no one gets fired for choosing IBM” effect. However, turnover rates impacting corporate operations differ from those affecting your trial directly. Therefore, selection criteria should explicitly reflect critical performance indicators (KPIs) to maintain alignment and accountability.
Key Considerations for CRO Selection Strategy:
· Clearly define expectations and needs.
· Prioritize team continuity and robust change management.
· Ensure financial transparency.
· Establish realistic expectations regarding FSO versus FSP model outcomes.
· Evaluate the size and management structure of potential CROs.
· Understand precisely what internal resources and support your team can provide.
Redefining the CRO Selection Strategy Question
Instead of asking, “Who’s the right CRO?” consider the more effective question, “What must I do to ensure my trial succeeds?” Success hinges on internal preparation, clear communication of needs, and flexibility in adapting to global operations and technological advancements.
Your ideal CRO could be a specialized niche provider offering personalized attention or a global powerhouse with extensive infrastructure. Success with either type depends on clearly defined expectations and robust planning.
Partnering for Future Success
Some people value the role of outsourcing and procurement, and others feel that Clinical Operations can do it fine without help. Regardless of your decision on support, realize that MSAs and contractual terms are there to establish guidance and document the lowest bar of quality acceptable to both sides. People manage people. Build the model that suits you best and bring out the best in your solution. If you have a good story on your CRO selection strategy or process, we would love to hear it. Contact our team today.