Clinical Solutions

Digitize clinical trial documentation and processes with eTMF software

Vault eTMF enables electronic Trial Master File management where all processes and documents are managed in one system, in real-time, as they are executed. Medtech clinical teams can actively govern content from start to finish, removing the need for external tracking spreadsheets and improving the overall efficiency of clinical trial processes.

Benefits

Stay Inspection Ready

Business-specific workflows ensure TMF content gets managed in real-time, enabling accurate reporting and better decision-making.

Full Visibility

Comprehensive reports and dashboards provide full visibility into TMF completeness, timeliness, and accuracy.

Always Accessible

Access with any device from any location, making it simple to author, upload, review, and approve documents.

Easy to Use

Simple functionality and an intuitive interface allow users to create, exchange, and update TMF documents.

Fast Implementation

Flexible configuration and cloud deployment allows companies to be up and running in weeks.

Features

Visibility into Trial Status

Trial managers and partners will know what’s required, what's completed, and what’s missing. Real-time dashboards and reports answer questions about progress, completeness, and help remedy process bottlenecks.

Document QC Workflow

Quality check workflows can be auto-triggered at the appropriate time to improve the accuracy of the eTMF on an ongoing basis. The layout allows users to review document content and metadata simultaneously.

TMF Reference Model Support

Full support for documents, properties, relationships, and hierarchies of the TMF Reference Model version 3.0 for both core and recommended documents.

Dynamic Security

Security and access controls determine level of access based on study team or role. Users can only interact with the documents relevant to them, reducing overall risk and improving quality.

Real-time Collaborative Authoring

Seamless integration between Vault eTMF and Microsoft Office Online provides real-time collaborative authoring on all clinical documents compliantly.

Study Binders

Multiple pieces of content can be bundled into a single binder, which can then be set as active or inactive for TMF archiving purposes. Final documents are protected and easily retrieved when needed.

Resources for Vault eTMF

Image for electronic Trial Master File Management Software for Inspection Readiness, Visibility, and Control
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electronic Trial Master File Management Software for Inspection Readiness, Visibility, and Control

Image for Fast-Growing Medtech Companies Gain Agility and Speed with Veeva MedTech Clinical Solutions
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Fast-Growing Medtech Companies Gain Agility and Speed with Veeva MedTech Clinical Solutions

Image for Brenda DeJesus shares how Veeva MedTech’s customer success management model is one of the best in the industry
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Brenda DeJesus shares how Veeva MedTech’s customer success management model is one of the best in the industry

Image for Jennifer Kerr, President at Cook Research, shares insight on how Cook Research is leveraging digital platforms
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Jennifer Kerr, President at Cook Research, shares insight on how Cook Research is leveraging digital platforms