Service Description

PPD was selected to manage a global registration trial. Scope of project included, country and site identification, regulatory, safety/PVG, trial management/monitoring, data management and biostats. PPD also had project management responsibility for coordinating IWR, clinical supply and imaging core lab vendors.

What Went Well

PPD has extensive experience in oncology. It is large enough to have global reach. It seems to have low turnover.

What Could Be Improved

A number of key individuals assigned were not the ones who attended the bid defense meeting. As a result, several individuals have been replaced on the project in the first 6 months. Start up activities have been behind schedule and PPD has to be prompted to constantly to be more proactive. PPD financial reports need improvement.

Lessons Learned from the Experience

PPD is a good CRO, but needs to be actively managed. As with all CROs, they need to be more proactive and demonstrate ownership in the project. They seem to do quality work, but sometimes at the expense of efficiency.