This survey report explores insights from 150 life science leaders about protocol development and strategies for minimizing the risk of amendments.
Protocol amendments can increase costs, disrupt recruitment, and delay clinical development. But they aren’t always inevitable. In fact, 95% of life science leaders surveyed said protocol amendments could be avoided at least some of the time.
The report examines where amendment risks can emerge during protocol development and what sponsors can do to address them earlier. It provides practical strategies for developing protocols that are scientifically sound, operationally feasible, and aligned with regulatory, site, and patient needs.
Download the report to learn:
- How to allocate the right amount of time for protocol development
- Why engaging external partners early can help identify and mitigate risk
- How site and patient input can improve feasibility and reduce trial burden
- How cross-functional expertise can strengthen protocol design and decision-making
- What to look for in an end-to-end partner to support protocol development