Service Description

CRO was contracted for all aspects of study operation (site selection, monitoring etc), safety, data management, and regulatory.

What Went Well

We were truly happy with the project managers assigned for the two studies. They had complete experience and command on the trial operations.

What Could Be Improved

The CRO lacked enough experience on sourcing supplies in Europe including the comparatpr. The sponsor ended up spending lot of time helping figuring out on how and from where to source the drug and some of the supplies which were very unique.

Lessons Learned from the Experience

While the CRO had good project managers and command of trial operations, the CRO lacked supply sourcing experience which bogged things down.