FDA EIR - Syneos Health - October 16, 2018

An FDA inspection of Syneos Health, a contract research organization (CRO) in Raleigh, NC, was conducted from October 9 to October 16, 2018. This comprehensive review, assigned by the Office of Scientific Investigations/CDER under Compliance Program Guidance Manual CPGM 7348.810, focused on the firm's monitoring and oversight responsibilities for a Phase 3 clinical trial, ALK5461-207, sponsored by Alkermes, Inc. The inspection involved reviewing study master files, site monitoring practices, adverse event handling, and data collection procedures across several investigator sites. While the inspection of Syneos Health itself did not identify any significant objectionable conditions or practices, and no FDA Form 483 was issued, the review highlighted issues at specific clinical investigator sites managed by Syneos Health. These included instances of potential "screening bias," adverse event reporting discrepancies, issues with DEA form accountability and informed consent documentation, various protocol deviations, a late Serious Adverse Event (SAE) report, and subjects signing incorrect informed consent forms. In response, Syneos Health had identified these concerns and initiated re-training for the affected sites to ensure compliance. The inspection report will be forwarded to CDER for final review and classification.