GCP Starts with a Complete, Audit-Ready TMF.

ClinAudits’ Audit Notes

✅ GCP Compliance Starts with a Complete, Audit-Ready TMF.

Your Clinical Trial’s Integrity Depends on It. Our Experts Ensure It’s Done Right.

Maintaining a complete and inspection-ready Trial Master File (TMF) is not just a regulatory requirement, it’s the backbone of clinical trial credibility, patient safety, and sponsor confidence. At ClinAudits, we specialize in GCP auditing services with a sharp focus on essential documents and TMF health across all phases of clinical research.

🔍 Our TMF & Essential Document Audit Services Include:

• ✅ TMF Structure & Completeness Check: We evaluate the presence and quality of all required essential documents per ICH E6(R2) and applicable regulatory guidelines.
• ✅ Filing Timeliness Review: We assess document filing against milestone timelines to ensure ALCOA-C principles are upheld.
• ✅ TMF Health Scorecard: Our detailed reporting pinpoints gaps, inconsistencies, and compliance risks.
• ✅ Pre-Inspection Readiness Audits: Avoid inspection surprises with our proactive compliance assessments.
• ✅ Remote or On-Site Audits: Flexible delivery options based on your study needs and audit scope.

Why Choose ClinAudits?

✔ Experienced GLOBALLY LOCATED GCP Auditors with 17+ years in clinical QA.
✔ Global TMF Expertise across paper, hybrid, and eTMF platforms.
✔ Regulatory Insight to support FDA, EMA, MHRA, and PMDA expectations and other regulatory authority experience.
✔ Actionable Recommendations to strengthen compliance and quality systems.

Your TMF tells the story of your trial. Let’s make sure it’s complete, compliant, and inspection-ready—every step of the way.

Interested in learning more about GCP auditing? Stay ahead of regulatory expectations with expert training and audit support. Contact us today! ClinAudits, LLC- Cheri Wilczek, President-email: cheri.wilczek@clinaudits.com; phone: 973 492 8108 extension 111. Our website is: www.clinaudits.com.

WHO WE ARE

ClinAudits is a highly specialized third-party provider of auditing and Consulting services in the areas of:

Good Clinical Practice (GCP)

Good Laboratory Practices (GLP)

Good Manufacturing Practices (GMP)

Good Pharmacovigilance/Drug Safety (GPV)

 Good Tissue Practice (GTP)

Risk Evaluation and Mitigation Strategy (REMS)

Since 1999, ClinAudits has completed over 6,000 projects, and we have

Grown to over 106 active consultants worldwide!