Control Monitoring Visits

Control Monitoring Visits

A US pharmaceutical company ran a large clinical trial in EU by subcontracting one of the biggest CROs. They asked us to oversight the skills and performance of the CRAs.  This is how we did it:
Preparation
Definition of two different approaches: vertical (key aspects of the study) and transversal (CRA responsibilities).

Creation of different checklists.

Elaboration of very detailed reports.

Outcome
Several deficiencies were detected
Measures taken
A training program on evaluation of the response was implemented.

Increase the frequency of review the MVR and close follow up the problems detected during the visits.

Client´s request

The client was so satisfied that asked us to develop an ad-hoc QC best practices training program. We delivered it to the staff in EU and EEUU.