Veeva eTMF

Veeva eTMF is a trial master file application designed for clinical operations teams at sponsors, CROs, and sites. It is built to ensure the quality, timeliness, and completeness of a TMF, and supports real-time inspection readiness through active document management. The platform has been available since 2012, is used by more than 500 organizations, and is described as very mature in its product lifecycle.

The application provides full enterprise content management capabilities, including document upload, version control, QC and approval workflows, and real-time co-authoring with Microsoft Office for study documents such as consent forms. It is designed to support global outsourcing models and facilitate collaboration between sponsors, CROs, and sites.

Core Document Management Capabilities

• Upload, version control, and approval workflows for TMF documents
• Real-time co-authoring with Microsoft Office for study documents including consent forms
• Expected Document Lists (EDLs) to manage completeness and timeliness of the TMF
• Automatic content file classification and matching to EDLs
• TMF Transfer feature for exchanging completed TMFs between sponsors and CROs at study close, eliminating end-of-study migrations

Risk-Based Document Quality Control

• Assigns a risk level to each document type and applies a corresponding sampling percentage
• Automatically determines whether a quality check is required when a new document enters a workflow
• Provides traceability to support the audit trail throughout the QC process

Veeva AI for Clinical Operations

• TMF Intake Agent: Automatically classifies, indexes, and adds key metadata to incoming TMF documents, reducing manual work and improving TMF quality
• Quality Check Agent: Reviews individual documents or sets of documents for completeness and accuracy to support TMF readiness

Inspection Readiness and Visibility

• Manages all TMF documents and processes within a single system to support ongoing inspection readiness
• Provides full traceability and historical accuracy across the TMF
• Gives sponsors, CROs, and sites a real-time view of TMF completeness
• Automates processes and surfaces insights to help study teams prioritize high-value activities

Reported Efficiency Outcomes

• More than 80% decrease in TMF migration preparation time
• 75% faster TMF delivery in outsourced models
• 40% reduction in study reconciliation time

Veeva eTMF is part of the Veeva Vault platform, a single cloud platform that also includes other clinical operations applications such as Veeva CTMS, Veeva Site Connect, Veeva Study Training, Veeva Payments, Veeva Study Startup, and Veeva RTSM, among others. This unified platform approach is intended to support broader clinical trial operations from a single system.