FDA EIR - Bracket Global, LLC - May 05, 2016

An FDA inspection of Bracket Global, LLC, a Contract Research Organization based in Feasterville-Trevose, PA, was conducted on May 5, 2016. This initial, directed inspection by the Office of Scientific Investigations, Center for Drug Evaluation and Research, followed Compliance Program Guidance Manual 7348.810, which governs Sponsors, Contract Research Organizations, and Monitors. The inspection's primary objective was to investigate an unblinding incident reported by a sponsor, where dose information was inadvertently revealed in Study Visit Notifications for multiple subjects across 30 clinical sites during a specific clinical trial. The main issue identified was "Unclear Requirements" related to the Interactive Web Response System (IWRS) that generated these notifications. The investigation confirmed this particular unblinding incident was isolated to the single clinical study under review. Bracket Global operates under a Quality Management System that adheres to FDA and international Good Clinical Practice regulations, as well as 21 CFR Part 11. In response to the incident, Bracket Global conducted a thorough investigation and implemented corrective actions, including revising the IWRS Requirements document (Version 9.0) to remove dose information from Study Visit Notifications. The company followed its established Corrective and Preventive Action (CAPA) procedures. Importantly, no Form FDA 483 was issued during the inspection, and no verbal observations were made, signifying that the company's response and current operations were found to be compliant within the regulatory framework.