Situation: A Phase 4 open label study needed to meet a commitment to FDA

The Success: A Phase 4, open-label, 52-week safety and efficacy study of a marketed oncology product was conducted as part of a commitment to FDA to extend the safety data available in the specified patient population beyond 6 months.

The sponsor had previously committed to FDA that the clinical study report (CSR) for the study would be submitted by the end of Q2. The sponsor had several significant delays, yet we were able to meet their needs by adding resources and working closely with the sponsor to address any questions during the generation of the draft CSR. The final CSR was delivered one week ahead of schedule!

Throughout this project, the sponsor commented on Rho’s attention to detail and clear communication. The Sponsor’s Research Study Manager said: