Frequently Asked Questions (FAQ) 

The ICH E6(R3) update introduces enhanced risk-based quality management, stronger sponsor and CRO oversight, and a greater focus on data integrity. For TMF management, this means:

• Emphasis on critical-to-quality (CTQ) factors—ensuring that essential TMF documents are properly managed.

• More defined sponsor oversight expectations—requiring sponsors to have structured processes for TMF monitoring.

• Clearer guidance on technology use—including system validation, audit trails, and data governance.

At ICE Consulting, we help sponsors navigate these updates, implement best practices, and ensure TMF compliance with ICH E6(R3).

📌 Want more details? Check out our full guide on the ICH E6(R3) transition.

TMF oversight ensures that all essential clinical trial documents are organized, complete, and inspection ready. Sponsors and CROs must actively manage their Trial Master File (TMF) to meet Good Clinical Practice (GCP) compliance and regulatory expectations. At ICE Consulting, we help teams strengthen TMF oversight by providing tailored strategies that ensure completeness, accuracy, and audit readiness.

Improving TMF compliance starts with clear processes, training, and engagement. At ICE Consulting, we follow our Inform, Connect, Engage (ICE) approach:

✅ Inform – Educating teams on why TMF management matters.
✅ Connect – Being accessible and bridging the gap between TMF knowledge and application.
✅ Engage – Encouraging active participation to strengthen TMF quality.

From TMF process development to vendor oversight, we help sponsors build compliance-driven TMF strategies.

An eTMF system improves accessibility, streamlines document management, and enhances regulatory compliance. Sponsors using platforms like Veeva Vault, Trial Interactive, Wingspan, and PhlexTMF benefit from:

✔ Real-time document tracking
✔ Increased efficiency & transparency
✔ Improved audit readiness

ICE Consulting provides expert eTMF implementation support, system transitions, and ongoing oversight to help sponsors optimize their TMF processes.

We offer hands-on expertise in all areas of TMF oversight, including:

📌 TMF process creation & implementation
📌 Inspection readiness & compliance strategies
📌 eTMF system support & training
📌 TMF vendor oversight & document management

Whether you need full TMF guidance or targeted support, we ensure your TMF remains organized, compliant, and audit ready.

Many sponsors outsource TMF management to vendors, but without proper oversight, document quality and compliance can suffer. We help sponsors establish:

• Clear expectations & workflows

•  Quality control measures

• Vendor compliance monitoring

Our expertise ensures that TMF vendors maintain the highest standards in alignment with GCP, ICH E6(R3), and regulatory expectations.