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.
Business-specific workflows ensure TMF content gets managed in real-time, enabling accurate reporting and better decision-making.
Comprehensive reports and dashboards provide full visibility into TMF completeness, timeliness, and accuracy.
Access with any device from any location, making it simple to author, upload, review, and approve documents.
Simple functionality and an intuitive interface allow users to create, exchange, and update TMF documents.
Flexible configuration and cloud deployment allows companies to be up and running in weeks.
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.
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.
Full support for documents, properties, relationships, and hierarchies of the TMF Reference Model version 3.0 for both core and recommended documents.
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.
Seamless integration between Vault eTMF and Microsoft Office Online provides real-time collaborative authoring on all clinical documents compliantly.
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.
electronic Trial Master File Management Software for Inspection Readiness, Visibility, and Control
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