FDA EIR - Medpace Clinical Pharmacology Unit - February 17, 2017

An FDA inspection of Medpace Clinical Pharmacology Unit in Cincinnati, OH, occurred from January 9 to February 17, 2017. This directed inspection, primarily focused on data integrity for bioequivalence studies supporting new drug applications, was conducted under Compliance Program 7348.001. Although no FDA Form 483 (Inspectional Observations) was issued, the inspection highlighted several areas for improvement.

Key issues included a protocol deviation in one study where blood samples were initially collected improperly, necessitating redraws and creating a discrepancy between submitted data and source records. Documentation practices were found inconsistent, specifically concerning overwriting in a subject’s medical history post-enrollment and the failure to secure a key pharmacist's signature on a delegation log before their employment ended. A delay in documenting staff training for protocol amendments was also observed, and a re-consent form for one subject initially lacked a required signature. The inspector also emphasized collecting retention samples from every shipment, not just selected ones, when required.

In response, Medpace Clinical Pharmacology Unit initiated several voluntary corrections. These actions included retraining lab technicians involved in the blood draw incident, seeking clarification from the IRB on adverse event and protocol deviation reporting, establishing a new project assistant role to verify delegation log signatures, and implementing additional staff training on comprehensive documentation practices, especially for screening data and subsequent updates.