Veeva eTMF logo

Veeva eTMF

Ensures quality, timeliness, and completeness of trial master files with enterprise content management and real-time collaboration.

Solution by Veeva Systems
Visit website

Overview

Veeva eTMF is a leading application designed to enhance the management of Trial Master Files (TMF), ensuring they are complete, timely, and of high quality. It provides comprehensive enterprise content management functionalities such as upload, version control, quality check/approval, and supports real-time collaboration using Microsoft Office for documents like consent forms.

The system is optimized for efficiency and supports global outsourcing, making it particularly useful in managing trials across diverse geographies. Key capabilities are enhanced through features like the Expected Document Lists (EDLs), which help manage document completeness and timeliness. The TMF Bot plays a critical role by automatically classifying content files and matching them to relevant EDLs.

The platform also simplifies the exchange of TMFs between sponsors and contract research organizations (CROs) through its TMF Transfer feature, which facilitates the transfer of completed TMFs at the study's conclusion.

Why Choose Veeva eTMF?

  • Inspection Readiness: Maintain a continuous state of readiness by managing all TMF documents and processes within a single system.
  • Enhanced Collaboration: Provides real-time insight into TMF completeness, enabling sponsors, CROs, and sites to collaborate more effectively.
  • Improved Efficiency: By automating processes, study teams can focus on high-value activities, gaining both visibility and efficiency.
  • Unified Operations: Accelerate trial processes with a comprehensive, single-platform approach to clinical operations.

Veeva eTMF is trusted by over 500 customers for its capability to automate and enhance TMF quality. Users report significant improvements in document processing speed and TMF quality, with substantial reductions in study reconciliation times by up to 40%, and enhanced TMF delivery speed by 75% in outsourced models. Additionally, the TMF Bot ensures over 98% accuracy in autoclassification of documents.

Numerous organizations, including Cancer Research UK and Merck, have noted increased efficiency and strengthened partnerships, contributing to faster delivery of treatments. Through its powerful features, Veeva eTMF provides in-depth insights that allow for iterative enhancements in the clinical process.

Meta

Category
Clinical Trial Management
Field(s)
Clinical & TrialsScientific IT & Integration
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic Professional
Tag(s)
Clinical Trials Management