GCP Audits

PVCON provides independent Good Clinical Practice (GCP) audits that verify clinical trial compliance with ICH-GCP E6(R2) guidelines, FDA 21 CFR Parts 11/50/56, and EU Clinical Trials Regulation. Our auditors evaluate investigator sites, clinical laboratories, and study documentation to ensure data integrity, patient safety, and protocol adherence.

We conduct GCP audits across all clinical development phases — from Phase I bioequivalence and bioanalytical studies through Phase II-IV trials. Our scope includes document audits covering protocols, informed consent forms, investigator brochures, CRFs, CSRs, PSURs, DSURs, and integrated safety summaries, as well as clinical database and biostatistics audits.

PVCON also performs IVRS audits, vendor qualification assessments, complete Trial Master File reviews for regulatory submissions, and FDA/EMA mock inspections. Our systematic approach ensures your clinical programs maintain audit-readiness throughout the study lifecycle and regulatory submission process.