Service Description

A controlled, 3-arm, open label, cross-over study included 46 healthy subjects on a controlled diet randomized into three treatment sequences to receive Phoslyra, PhosLo Gelcaps, or calcium citrate (positive control) with a 5

What Went Well

Parexel performed the study in the timely manner. Was proactive in anticipating our needs, as well as providing expertise when needed. Additionally, Parexel helped to optimize our regulatory strategy.

What Could Be Improved

One of the elements which I'd like to see improved is the communication aspect. Even in light of the fact that the study went well, several times I felt that we had to express our concerns regarding the overall direction of the study. In reality, it was just a matter of having a good project manager.

Lessons Learned from the Experience

Yes, Parexel thought outside of the box and provided us with solutions to optimize one of the arms of the study by enrolling more healthy volunteers. Their actions allowed to improve power of the trial, which in turn resulted in positive submission outcomes to the FDA