Service Description

The CRO was contracted to run all aspects of a multi-center Phase III clinical study including identifying sites, contracting sites, establishing drug supply, making regulatory submissions and monitoring clinical sites.

What Went Well

All aspects of the study startup and execution have gone very well. Of particular note was the CROs work in helping sites recruit study subjects.

What Could Be Improved

At this stage, the study has just randomized. To date there are no gaps in Quintiles performance and no issues.

Lessons Learned from the Experience

We employed Quintiles for this study due to their historical experience in the particular therapy area. This afforded the opportunity to leverage established connections and relationships with investigators which resulted in very active recruiting and highly motivated sites and subjects.