FDA EIR - Quintiles - May 19, 2017

An FDA inspection of Quintiles IMS, a contract research organization (CRO) based in Durham, NC, was conducted from May 16-19, 2017. This high-priority inspection was performed under Compliance Program 7348.810, focusing on sponsors, CROs, and monitors, specifically reviewing Quintiles' transfer of obligations, administration, and conduct of activities for a particular clinical protocol. The inspection concluded with no significant findings, and no Form FDA 483, Inspection Observations, was issued. Management was cooperative, providing all requested information. Quintiles IMS operates as a full-service CRO managing clinical development and trial management for medical product-sponsored studies. The company assumed responsibilities including clinical project management, site identification, monitoring, and data management. While the inspection found no regulatory violations by Quintiles, the review of specific study sites revealed instances of protocol deviations, such as issues with subject eligibility, informed consent documentation, and incomplete study procedures. However, Quintiles' monitors consistently identified these deviations, provided retraining to site staff, initiated additional monitoring visits, and implemented corrective actions like recruitment holds, ensuring resolution. This demonstrated adequate oversight by Quintiles IMS over the clinical trial and monitoring activities. No further regulatory actions were required, though the firm was reminded of the ongoing importance of adhering to regulations.