Veeva Vault eTMF

Improve Trial Efficiency and
Inspection Readiness with Vault eTMF

Enable ongoing inspection readiness with automation and
connectivity across business functions and stakeholders.

Announced 2012 Status Very Mature Customers 100+
Vault eTMF | Improve Trial Efficiency & Inspection Readiness
See how 450+ organizations address critical challenges with Vault eTMF innovations
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Overview

Use intelligent automation
in Vault eTMF to improve
TMF management

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Leading trial master file application

Veeva Vault eTMF is the leading trial master file application used to ensure the quality, timeliness, and completeness of a TMF.

Enterprise content management capabilities

It provides full enterprise content management capabilities for upload, version control, QC and approval, and real-time co-authoring with Microsoft Office for study documents such as consent forms. It’s highly efficient and performant and supports global outsourcing.

Compliance and collaboration workflows

Completeness and timeliness are managed through Expected Document Lists (EDLs). Content files are auto-classified through the TMF Bot, and classified content is matched automatically to EDLs. The TMF Transfer feature simplifies exchange between sponsors and CROs by sending completed TMFs at study close.

Impact

Efficient and compliant trials

>98%

TMF Bot auto-classification accuracy

75%

faster TMF delivery in outsourced models

40%

cut in study reconciliation time

Why Vault eTMF

Innovations to drive efficiency and quality

Stay inspection ready

Ensure ongoing inspection readiness by managing all TMF documents and processes in the same system.

Improve study partner collaboration

Give a real-time view of TMF completeness for sponsors, CROs, and sites to work together.

Gain visibility and efficiency

Automate processes and derive insights to focus study teams on the highest-value activities.

Unify clinical operations

Speed trials with the most comprehensive suite of clinical applications on a single cloud platform.

Customer Success

Trusted by 450+ customers to
automate and ensure TMF quality

Alcon Alexion AstraZeneca Atlantic-Research-Group Celerion Cerevel Daiichi-Sankyo Edwards Excelya Fortrea Heron KCR LEO Linical Lotus Merck Moderna Ora Regeneron Replimune UroGen

“We are processing documents more quickly and efficiently with Vault eTMF and the TMF Bot … while increasing the overall quality of the TMF.”

Stephen van Arcken, Senior Clinical Oversight Lead
Cerevel
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“Vault eTMF helps us maximize clinical trial efficiency and strengthen our partnerships to accelerate the delivery of treatments to patients.”

Nigel Blackburn, Director of Drug Development
Cancer Research UK
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“We now have rich insights about our clinical process, affording Merck the critical chance to make iterative and long-term improvements.”

Bryan Souder, TMF Head
Merck
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Resources

Explore and Learn

View features brief
Find Vault eTMF features to drive TMF health
Watch customer video
Moderna leverages eTMF to enable automation and connectivity
Watch customer video
Cerevel increases document processing efficiency by 40% with AI
Read case study
UroGen Pharma streamlines clinical and regulatory operations
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Quickly transfer TMF documents and eliminate end-of-study migrations
Watch demo
Process documents quickly and increase quality with the TMF Bot
Watch demo
Gain important information about inspection readiness on the Vault eTMF homepage
Read white paper
Create a culture of quality with Vault eTMF
Get checklist
Learn key SOP sections and other tips to prepare for inspections

Interested in learning more?

Contact Us Download Product Sheet