Service Description

INC was contracted to perform project management, clinical monitoring, study start-up, and site management for a Phase III type 2 diabetes trial. The primary endpoint of this trial was CV outcomes, so it was a long term study. Site contracting, data management and biostatistics services were retained in house at the sponsor.

What Went Well

The CRO initially met expectations during the study start up phase. The sites were activated, for the most part, along expected and agreed timelines. Delays to start up largely were outside of the CRO's control, related to site contracting which was retained in house. The CRO staff initially were enthusiastic and engaged in the study.

What Could Be Improved

The site management of the study sites was not aligned with the sponsor's standards and expectations. The study team (PM, CRA, and site managers) did not grasp the importance of retaining patients and sites over the long term to ensure collection of primary endpoint data. The monitoring was of poor quality (trip report late, mistakes in source monitoring & drug accountability, not engaging sites in regards to retention discussions, etc.). Despite multiple meetings with the sponsor, the services were eventually terminated early and the study taken back in house. Since taking the study back in house, patient & site retention has improved significantly.

Lessons Learned from the Experience

We at the sponsor should have set up a more robust governance structure in the beginning of the trial. Our oversight of the CRO and the quality was insufficient. Problems could have been detected earlier and course corrections could have been more swiftly requested and implemented. Our training of the CRO study team should have been more thorough and more focused on the importance of retention of subjects and sites. We engaged the CRO around this much too late. The CRO may have performed better if we had done a better job on our end; however, the CRO also failed to engage sufficiently with the sites, and their enthusiasm for the study waned much too quickly. They also failed to correct the quality issues with their monitoring staff.