Trial Master File services

A Trial Master File (TMF) Inspection is the official regulatory review of documents, facilities, records, and any other resources related to a clinical trial. This information may be located at the trial site, at the sponsor’s and/or CRO's facilities, or at other establishments. Because of the scope, breadth, and complexity of this material, building an inspection-ready TMF is a continuous process rather than simply a one-time event.

A leader in TMF innovation

ICON began providing dedicated eTMF services in 2005. Recognising the changes in expectations for Trial Master Files from regulatory agencies, specifically the US FDA, EMA and MHRA, ICON established a TMF operations centre to provide specialised eTMF services.

In 2012, ICON was one of the first CROs to establish a dedicated TMF Lead/Manager role to provide focus on TMF management. Today, the role has evolved to represent the industry’s best talent for managing TMF systems and processes. ICON’s TMF Leads/Managers bring technical competency, process knowledge, and people management skills. They work with the full TMF operations team to support project teams and customers in maintaining an inspection-ready environment at all times.

End-to-end TMF management and support

ICON offers expertise in end-to-end services for complete, transparent and inspection-ready TMFs. We have experience delivering to a consistently high standard on most industry-leading eTMF systems, as well as on our own robust, proprietary customised eTMF system, ICOMaster, which is aligned with the most recent version of the industry standard TMF Reference Model.

ICOMaster auto-files 50% of documents from source systems through advanced and intelligent system automation and integration, while RPA (Robotic Process Automation) in numerous centralised eTMF processes ensures timely, compliant and efficient eTMFs.

We also have the capability to offer automation and integration for Veeva Vault and Phlex eTMFs. ICON has a robust eTMF health metrics and governance structure to provide deep-dive insights into a study’s TMF health on a real-time basis, to ensure inspection readiness. 

• Centralised TMF management: Management of eTMF related processes from our centralised hubs across multiple regions: Americas, Europe & APAC. This helps reduce cycle time and control costs
• Complete end-to-end eTMF management: Including set-up, maintenance, quality control, and close out by assigned dedicated expert TMF Lead
• eTMF consultancy: TMF subject matter experts to help solve complex challenges and guide business decisions on eTMF processes, system set-up, roll-out and change management
• TMF conversion: Expertise to convert paper TMF to eTMF, migrating studies from one eTMF to another eTMF