Service Description

Monitor clinical trial sites for recruitment, source data monitoring and drug accountability and prepared clinical trial site for regulatory inspection. They were also responsible for study Site staff training.

What Went Well

They were very good at staff training and providing monitoring oversight. Trial site feasibility allow us to meet our enrollment criteria and close monitoring allowed us to meet all our milestones and data commitments. Regulatory inspection was very successful without any major issues and all training and oversight issues were addressed to the inspectors satisfaction.

What Could Be Improved

The CRO could have improved in sponsor communication and issue escalation. We could have better documented plans correct handling both these concerns. If the crowd has put written plans in place before the study start it would have improved both of these concerns. Delayed issue escalation in training and monitoring caused some minor data collection modifications and fire drill to make some time lines

Lessons Learned from the Experience

The CRO was fast to respond to the needs and concerns of the sponsor once these needs were identified. We learned that developing an up front relationship plan including communication and issue escalation would have been timely. The CRO has a very good quality control plan and CRA line management capabilities. We would work with this CRO again.