Service Description

The CRO was contracted to conduct all aspects of the Phase 1 clinical study. The study was conducted at their Phase 1 unit. Data was analyzed at their German data management facility. Report writing occurred at their US facility.

What Went Well

The clinical conduct of the study was excellent. The clinical unit was very experienced, well organized and well managed. Recruitment for the study was conducted fully within the estimated timeframe and the study was completed on time.

What Could Be Improved

There were two major elements that could have been improved. One was the organization and conduct by the in-clinic pharmacy. The system and quality control in the pharmacy was lacking. The other difficulty was the management and conduct of the overseas data management group. The data management group seemed to be unfamiliar with our study and behind on the timelines for their part of the study.

Lessons Learned from the Experience

The major lesson learned was that we, the Sponsor, need to better ensure that the CRO personnel are trained on our study and that the project manager for the study has all the different functional groups trained and aware of the timelines and procedures for the study.