Managing 24 Protocol Amendments Across A Complex Development Program
This case study explores a CRO’s high-profile clinical program involving five Phase III trials which required 24 system amendments within six months. Discover beneficial system changes that were implemented by the industry’s leading Interactive Response Technology (IRT) provider to keep this high-stakes clinical program on track for both the sponsor organization and the CRO.
You will learn:
- What changes would impact the programming already created
- The contingency plan needed to be put in place should the changes not be “live” in time
- Expert advice for making system amendments, reporting requirements, and contractual obligations for each organization