FDA EIR - Perceptive Informatics LLC - March 22, 2018

An FDA inspection of Parexel, a contract research organization in Billerica, MA, was conducted from March 19-22, 2018. This preannounced inspection, carried out under the CDER Office of Scientific Investigations and Compliance Program 7348.810 for Sponsors, Contract Research Organizations, and Monitors, focused on the company's independent radiology review processes for a specific clinical project.

The inspection thoroughly verified various operational aspects, including the objective response rate for 90 subjects, radiologist qualifications, site selection, training of image research associates, and adherence to the Independent Review Charter. Reviewers also assessed image quality control, data change requests, query reports, intra- and inter-reviewer quality assessments, and data handling procedures. Electronic data systems, their validation, and audit trails were also scrutinized.

Crucially, the inspection concluded with no deviations from the project charter or federal regulations. No discrepancies were identified during data verification, and all data changes were fully supported and compliant. Consequently, no FDA Form 483 was issued, indicating no objectionable conditions were found. The inspection did not mandate any specific corrective actions, with the inspector only providing general regulatory reminders to management.