Service Description

Monitoring + project management, study report. They also handled data management and assisted with the DSMB. Phase 3, 25 site US + Canada 420 subjects.

What Went Well

They have a good network of sites to work with and the CRAs had a good relationship with the sites. Additionally the therapeutic area was well understood by the team requiring minimal training. Their was minimal team turn over during the course of the study.

What Could Be Improved

Communications were not optimal, and we often heard about problems late. A site would have no enrollment for awhile and we would then learn the investigator left the practice with no one to continue the study at that site. Timelines proposed for enrollment were overly optimistic as it took much longer to enroll than expected.

Lessons Learned from the Experience

CROs are only as good as the specific team you have working on the project. Its also very dependent on personnel turn over. With minimal turnover you have a much better experience. Experience allows teams to be more efficient and proactive.