Trusted TMF expertise — Member, CDISC TMF Reference Model Steering Committee.
At ICE Consulting, we help sponsors stay inspection-ready with practical, GCP-aligned Trial Master File (TMF) strategies. Whether it’s maintaining compliance, improving TMF oversight, or simplifying document management, we focus on real solutions that make a difference.
We believe that TMF health relies on the study team’s understanding of the TMF—which is why our approach is built on Inform, Connect, and Engage. We inform teams by clarifying the “why” behind TMF expectations, connect by being accessible and bridging the gap between their knowledge and TMF requirements, and engage by fostering active participation in TMF processes.
With extensive experience across industry-leading eTMF and document management systems—including Veeva Vault, Trial Interactive, Wingspan, PhlexTMF, Medidata RCM, ClinTrak, SharePoint, and various custom-built platforms—we provide the expertise and guidance sponsors need to confidently manage their TMF.
Simply put, the TMF is the foundation of a clinical trial because it provides a central location for all essential documents that tell the full story of the study.
Per ICH E6(R3):
"Essential documents should be managed in a way that ensures oversight, enables evaluation of the trial’s conduct, and supports the reliability and quality of the data produced."
Think of it like a puzzle. Every function in a trial—data management, safety, monitoring, and beyond—is a puzzle piece. The TMF is where all those pieces come together to form the full picture. If a piece is missing or out of place, the image is incomplete, and inspectors will notice.
That’s why the TMF should always be inspection ready. It’s not just a collection of documents; it’s evidence of how the trial was conducted. Regulatory authorities rely on it to assess compliance, ensure data integrity, and confirm that every part of the study was handled properly.
