Service Description

PPD was contracted to perform a phase 2 proof of concept, safety and efficacy study in the US and EU. PPD was contracted to provide study feasibility, identify, manage and monitor sites, data management and analysis.

What Went Well

CRO was organized and experienced in the indication with numerous studies recently conducted in the indication. CRO was able to leverage this experience and make recommendations as to particular countries/sites to utilize/avoid. CRO was efficient to the point that often they were waiting on our organization to complete key tasks in order to proceed with the study.

What Could Be Improved

I am overall very happy with the level of service. One area of improvement would be the level of participation of some of the recommended sites. A handful of the sites underperformed and despite a good feasibility report and recommendation from the CRO, really were not worth the time and expense of opening them. It is understood that in almost every study there are underperforming sites and that sometimes specific aspects of the protocol and competing trials lead to lack of performance, but this was the largest area for improvement for the study.

Lessons Learned from the Experience

The biggest lesson learned was to perhaps more carefully review recommended sites prior to selection, though performance can be difficult to predict, particularly with sites that had performed well in the past. The CRO did think outside the box on a number of occasions in order to help us keep to our self imposed timelines for study initiation. Suggestions were made to speed site initiations by beginning the selection/contracting/submission process in parallel with regulatory submissions that allowed a quicker start up than if we had done them in sequence. I learned that experience in the indication is important as it can help to avoid mistakes down the road. The CRO used its own lessons learned from other studies to guide us and help avoid potential issues.