Early FPI and Centralized ePRO Monitoring Lead to Success for a Phase 2 Osteoarthritis Study
Situation: A Phase 2 Osteoarthritis of the knee study
- Completed enrollment of the trial’s subjects several weeks ahead of schedule because of strong site relationships and experienced CRAs.
- Centrally monitored ePRO compliance after a noticeable decline. CRAs noticed a decline in ePRO compliance, and within a day and with no impact to the budget, Rho experts programmed a heatmap of ePRO compliance for each subject. This allowed the sponsor and CRAs to monitor for and ensure timely compliance of one of the study’s critical endpoints.
- Our Sponsor was incredibly pleased with the successful execution of their trial.
For all the challenges that we face, Rho creatively develops solutions and adapts to the changing landscape of clinical studies while working within established high quality processes.
Polina Bukshpun, Associate Director, Clinical Operations, UNITY Biotechnology