FDA EIR - Syneos Health - October 16, 2018

An FDA inspection of Syneos Health, a Contract Research Organization (CRO) located in Raleigh, NC, took place from October 9-16, 2018. This comprehensive inspection, conducted under Compliance Program Guidance Manual 7348.810, focused on the CRO's oversight and monitoring of clinical investigator sites for Protocol ALK5461-207, a Phase 3 efficacy and safety study for Major Depressive Disorder sponsored by Alkermes, Inc. Crucially, the inspection identified no significant objectionable conditions or practices, and consequently, no FDA Form 483 was issued. While no regulatory violations were cited, Syneos Health's internal monitoring did identify several areas for improvement at various clinical sites. These included instances of 'screening bias,' potential issues with informed consent documentation (missing signatures/dates), identified protocol deviations, a serious adverse event (SAE) reported late to an Institutional Review Board, and the use of incorrect informed consent form versions by some study subjects. As a result, Syneos Health initiated re-training for certain sites to address these observations. The inspection concluded with the report being submitted to CDER for final review and classification.