Service Description

The CRO was contracted to to perform a clinical pharmacology study involving different treatments and biomarker assessments at three sites. This included protocol, regulatory submission, site set up, preparation of medication, subcontracting of bioanalytical labs and ECG lab, conduct, DM, data evaluation, and report writing.

What Went Well

The CRO was very proactive during the planning phase of the study. They offered solutions for operational issues. The study was set up in a short time period. The conduct and coordination was managed very well.

What Could Be Improved

The CRO could improve in managing sub-contractors. There was much more direct contact between sponsor and sub-contractors as expected. The departments involved in the DM and evaluation were somehow disconnected to the remaining CRO study team. Moreover, there were a number of personnal changes in team members from these departments. Both the disconnect and team changes lead to mistakes and delays.

Lessons Learned from the Experience

The CRO appears to be good for standard services. More complex/specific tasks such as managing specialized subcontractors can be improved.