Compliance
GCP Vendor Oversight: What the Regulations Actually Require
GCP vendor oversight, clause by clause: what ICH E6(R3), 21 CFR 312.52 and EU CTR 536/2014 require of sponsors — and what inspectors actually check.
Jul 3, 2026
Compliance
Clinical Trial Vendor Audits: A Risk-Based Program
Clinical trial vendor audits are a risk-based decision, not a calendar ritual — a program, independent of monitoring, that audits where risk warrants.
Jun 19, 2026