GxP Auditing Services

Good Clinical Practice (GCP) Auditing

Independent GCP audits to verify clinical trial integrity, protect patient safety, and ensure data reliability, in full compliance with FDA, ICH E6(R2), and global regulatory standards.

ICH E6(R2) 21 CFR Part 312 Clinical Site Audits CRO Audits TMF Review

Ensuring Clinical Trial Integrity and Regulatory Compliance

Clinical research operates in one of the most heavily scrutinized regulatory environments in life sciences. GxP Global Quality Network's GCP auditing services provide sponsors, CROs, and academic research organizations with the independent oversight needed to ensure trial integrity, data reliability, and patient protection.

Our GCP audits are conducted in accordance with ICH E6(R2) Good Clinical Practice guidelines, FDA regulations (21 CFR Parts 50, 54, 56, 312), and applicable EU Clinical Trials Regulation, providing you with defensible, comprehensive audit findings.

GCP Audit Services

Clinical investigator site audits (routine, for-cause, pre-approval)
Contract research organization (CRO) qualification and oversight audits
Sponsor quality assurance system audits
Investigational product (IP) management and accountability audits
Trial Master File (TMF) completeness and quality reviews
IRB/IEC and informed consent process audits
Central laboratory and specialty laboratory audits
Clinical data management and biostatistics audits

Key Areas of Evaluation

Protocol adherence and deviation management
Informed consent processes and documentation
Subject eligibility, enrollment, and retention practices
Investigational product storage, dispensing, and accountability
Safety reporting: AE/SAE identification and reporting timelines
Data accuracy, completeness, and source document verification
Regulatory file maintenance and sponsor oversight documentation

Deliverables

All GCP audit reports include: site-specific findings with risk classification, regulatory citation references, sponsor/CRO recommendations, and a CAPA response template to facilitate timely corrective actions and regulatory response preparation.

Quality standard: All GxP Global Quality Network engagements are led by senior-credentialed auditors with 20+ years of active GxP audit experience, regulatory currency across FDA, EMA, MHRA, and Health Canada standards, and direct accountability for every deliverable.