The relationship between sponsors and Contract Research Organizations (CROs) in clinical trials requires careful balancing of oversight responsibilities, industry experts emphasized at Veeva's Clinical Operations Outsourcing 2024 Forum in Milan. The discussion highlighted the critical nature of finding the right equilibrium between monitoring and autonomy in trial management.
Ed Fowler, VP of operation excellence at Parexel, presented a "Goldilocks" approach to sponsor oversight, emphasizing that neither extreme is beneficial. "Too little oversight and you have misaligned deliverables, deviation from project goals, quality issues, and disjointed teams," Fowler explained. "Too much oversight gets expensive... and can stifle the CRO's creativity and efficiency."
Challenges in Sponsor-CRO Relationships
Emma Forrest, head of R&D operations at Recordati, highlighted the challenges sponsors face when CROs underperform. "There was no way we could run a fully outsourced model by relying on the CROs, no one is going to treat your trial with as much heart as you do," she noted, emphasizing the importance of maintaining control through electronic Trial Master File (eTMF) systems.
Establishing Early Collaboration Framework
Evgenia Delyagina, head of TMF operations at Debiopharm, stressed the importance of setting clear expectations from the initial engagement. "It starts very early when we start our discussions with a CRO. There will be a clear requirement that a CRO has to work in our interior system," she stated, highlighting how this approach ensures proper document access and control.
The Impact of Trial Complexity
The need for effective oversight becomes even more critical as trials grow in complexity. Pinar Bérénice Bénet, senior director of strategy at Veeva Systems, explained: "More companies are conducting more complex studies to be able to reduce timelines to reach the market... companies are now putting all those stages together in an umbrella trial with multiple arms."
Best Practices for Oversight
Pooja Purewal, associate project director for biotechs at Parexel, emphasized transparency as key to maintaining balanced relationships. She advocated for:
- Clear definition of roles and responsibilities from study initiation
- Regular "pulse checks" throughout the study
- Established governance frameworks at both study and partnership levels
- Consistent communication protocols
The increasing complexity of clinical trials, particularly in specialized areas like cell and gene therapies, makes effective sponsor oversight more crucial than ever. Industry experts agree that success lies in finding the right balance - maintaining sufficient oversight to ensure quality and compliance while allowing CROs enough autonomy to operate efficiently.
