FDA EIR - Syneos Health - August 05, 2019

An FDA inspection of Syneos Health, a contract research organization (CRO) located in Morrisville, NC, was conducted from July 29 to August 5, 2019. This comprehensive review, assigned by the Office of Scientific Investigations/CDER and guided by Compliance Program Guidance Manual CPGM 7348.810 for Bioresearch Monitoring of CROs, focused on the firm's oversight of clinical investigator sites for an investigational FDA-regulated drug study. The inspection's primary objective was to assess Syneos Health's site monitoring and sponsor/CRO oversight, specifically reviewing six assigned clinical investigator sites out of 473 global locations. The scope included examining the study master file, standard operating procedures related to site monitoring, adverse event handling, and data collection, as well as the CRO's response to non-compliant sites. Crucially, the inspection did not identify any significant objectionable conditions or practices at Syneos Health, and consequently, no FDA Form 483 was issued. While Syneos Health itself demonstrated compliance, the report detailed instances where the CRO identified issues at some clinical investigator sites under its purview. For example, site #608 was noted for administering investigational product to incorrect subjects, and site #284 faced challenges including informed consent issues, low adverse event reporting, high screen failure, and significant principal investigator turnover. Several other sites were terminated for compliance issues, such as lack of principal investigator oversight or failure to address IRB audit findings. These site-specific issues were managed by Syneos Health through corrective action plans or site terminations. No regulatory actions were required for Syneos Health.