FDA EIR - Syneos Health - September 11, 2019

An FDA inspection of Syneos Health, Inc., formerly known as InVentiv Health Clinical Research Services, in Miami, FL, was conducted from September 9-11, 2019. This surveillance, data integrity, and user fee PDUFA inspection was initiated by the CDER’s Office of Study Integrity and Surveillance and followed regulatory guidelines outlined in CP 7348.003 for In Vivo Bioavailability-Bioequivalence Studies. The inspection specifically reviewed Protocol 162020 for a comparative bioavailability study of Riluzole 50 mg. The review encompassed various aspects of clinical trial conduct, including source documentation, informed consent processes, IRB oversight, study monitoring, investigational product reconciliation, and electronic medical records. The inspection concluded with no significant deficiencies regarding FDA regulations. Consequently, no Form FDA 483, Inspectional Observations, was issued, and no warnings were given to management. The facility demonstrated satisfactory adherence to established protocols and regulatory guidelines, indicating no required actions.