Service Description

Phase I protocol writing

What Went Well

The protocol writing did not go well and was used as a test for the Phase I study we are conducting at another CRO.

What Could Be Improved

A better understanding of the statistics for the biosimilar study design. The protocol was contracted to a third party and not written by Parexel. Getting in touch with the sales representative was difficult.

Lessons Learned from the Experience

We learned that our project may have been too small for Parexel and were given a less experienced team.