Service Description

A Phase 3 pivotal study for licensure in 1-north-american markets was outsourced to Quintiles. Quintiles was contracted to monitor the clinical study, recruit subjects and make Regulatory filings in non-US markets to support study conduct.

What Went Well

Quintiles has prior expertise in conducting the type of study we contracted and we have worked with them in the past. They provided good advice in interacting with the Canadian Health Authority. Quintiles has provided very good clinical monitoring and has identified GCP issues with one investigator that led to the closure of that clinical site.

What Could Be Improved

The contract negotiation process is always difficult in these programs. It would be easier of Quintiles had more standardized approaches to contract negotiation and study pricing. It took some time to completely delineate responsibility for Regulatory filings in each market between Quintiles and ourselves.

Lessons Learned from the Experience

We learned that it is never too early to begin the contract negotiation process, even with a preferred vendor. We learned to trust Quintiles' clinical monitoring and that they bring a great deal of study conduct expertise to the table. In addition, since we have run similar studies with Quintiles in the past, it is good to see that a consistency has been maintained with regard to specific expertise in the particular clinical evaluations.