FDA EIR - VirtualScopics, LLC. - October 12, 2017

An FDA inspection of VirtualScopics, LLC., an imaging Contract Research Organization (CRO) and central reader, was conducted from October 10-12, 2017, in Rochester, NY. This high-priority Center for Drug Evaluation and Research (CDER) inspection focused on data integrity for a New Drug Application (NDA), operating under Good Clinical Practice (GCP) assessment principles for CROs. The primary objective was to verify VirtualScopics' adherence to sponsor-related responsibilities for independent, blinded central imaging reviews and the accuracy of source data generated for a specific clinical study supporting the NDA.Investigators meticulously reviewed the firm's compliance with the study protocol, Imaging Review Charter, written standard operating procedures, and applicable regulations. They verified tumor response data points for 26 randomly selected subjects by comparing VirtualScopics' source documents with sponsor-submitted data. The inspection concluded without any significant observations of non-compliance or data integrity issues. No discrepancies were found, and the company's assessments, image analysis procedures, and overall compliance were deemed adequate. As a result, no Form FDA-483, Inspectional Observation, was issued, and no corrective actions were required, mirroring the positive outcome of their previous inspection in 2014.