Service Description

Quintiles was contracted to run a large Phase 3 study in allergic rhinitis being conducted in US and Canada. Quintiles has responsibility for overseening recruitment and site monitoring. The also have responsibility for regulatory submission of CTA documentation in Canada. Our company covers submissions to FDA for this study.

What Went Well

Quintiles performed the intitial site startup activities well. Regulatory submissions were made on time. Investigator training was accomplished in the appropriate timing and was well carried out.

What Could Be Improved

There have been recurrent issues with the clinical monitoring provided by Quintiles. We have had a couple of sites that have been cited for GCP violations that should have been caught earlier in the process and not allowed to escalate. In addition, we have found a poor line of communication of late from Quintiles which surprises us as we have used Quintiles for other similar studies and did not have this experience.

Lessons Learned from the Experience

We have learned that past experience does not always predict future performance when it comes to CROs. In addtion, part of th issue may stem from internal decisions on how we interact with CROs in the clinical space. Due to internal down-sizing, a strategic decision was made to turn over more of the clinical oversight to the CRO. In retrospect this was a poor policy. Our organization has amended this policy and we now approach working with clinical CROs as more of a partnership.