Service Description

CRO was contracted to oversee the management of a Phase I clinical trial to start in North America and expand to Asia with a Phase II expansion (dependent upon results of the Phase I cohorts. Sites were to be identified and initiated across North America and centres in Asia.

What Went Well

Identifying sites was done relatively well. good site and strong motivated investigators were identified. Fairly accurate start-up timelines were generated. Initiate site startup was dont on time in a compressed schedule, meeting their promised target.

What Could Be Improved

Some issues that should have been identified at site identification were not discovered until Site selection visits, delaying site initiation. Some investigators ended up having too many trials to actually be effective. Some IRBs were too swamped to review our trial in an adequate timeframe. All issues should have been identified earlier. Some of the trial management documentation was significantly delayed in being created.

Lessons Learned from the Experience

We learned that even experienced CROs need to have their hand held often to ensure nothing falls through the cracks. Chossing a large CRO doesn't necessarily guarantee quality. While Quintiles is one of the largest CROs, they still often have junior staff depending on the size of project and size of sponsor company, and one needs to ensure you still get an experiences study manager as the main point of contact.