Service Description

PPD was contracted to manage a global pivotal phase III trial in lung cancer for novel immunotherapeutic agent. Site management, including selection, initiation, monitoring, closeout, data management, biostatistics, safety.

What Went Well

PPD had global presence and therapeutic expertise as well as a deep talent pool. They did attempt to partner with us the client rather than approach as a fee for service relationship

What Could Be Improved

As typical in the CRO industry, there was initial switch and bait as the bid defense team was not who was assigned to the project at award. The project got off to a slow start and we had to insist on replacing a few key project members.

Lessons Learned from the Experience

CRO needs to be constantly monitored and managed. If we don't expect and demand full accountability, timelines and quality slip.