Achieving Success After Rescuing a Neglected Study
Situation: Rescuing a Phase 3 periodontal study
The Success: We rescued a Phase 3 periodontal disease study after a nine month gap with no study activity. We inherited over 600 casebooks of data that had not been entered or monitored. We got the study back on track by:
- Entering and cleaning all backlogged data
- Assisting the sponsor with discussions with FDA
- Catch-up monitoring and new visit monitoring, including having monitors on site during patient visits. The CRAs worked closely with the DM lead to ensure all queries on old data addressed and verified.
- Holding a new kick-off and training to retrain and re-energize sites and ensure their on-going effort