In August of 2019, Medpace Core Laboratories (MCL) successfully completed a comprehensive inspection by the United States Food and Drug Administration (FDA). The inspection focused on a late phase, registrational, oncology trial and concluded with no major or minor findings, reflecting the high quality and systematic execution of the trial by MCL. The inspection process was carried out at the Cincinnati headquarters of MCL by an FDA inspector, with oversight from the Medpace Quality Assurance team.
The FDA evaluated MCL standard operating procedures, image management and quantitation tools, as well as project and data management processes. The inspection’s success is a testament to the capability of MCL to carry out clinical trials with efficiency, rigor, and high standards for data protection.
MCL prides itself on maintaining a culture of rigorous quality assurance with fully-validated and integrated image management systems that are compliant with Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR), and FDA Guidance for Industry on Clinical Trial Imaging Endpoint Process Standards. MCL systems and processes are designed to ensure data integrity, which allows the lab to operate in a continued state of regulatory readiness.
“The quality of our work is a point of pride for our staff and critical to our continued growth as a core imaging laboratory. The success of this recent FDA inspection reflects well on our people, our processes, and our systems”, stated Daniel H. O’Leary, M.D., Sr. Vice-President, Medpace.
Medpace Core Laboratories provide robust, comprehensive imaging and cardiac safety capabilities to enhance and expedite biopharmaceutical development across therapeutic areas. The global clinical trial experience at MCL ensures that imaging and cardiovascular components are seamlessly integrated into the complex structure of the overall clinical trial for both stand-alone projects and fully integrated projects with the Medpace clinical team.