Improve visibility and readiness with Nucleus eTMF

Collate and control your electronic trial master file documents with ease using our centralized regulatory document management solution.

Control your Trial Master File documents from Study Startup to Regulatory Submission

Nucleus eTMF allows your team to control submission documentation and maintain inspection readiness via a simple, intuitive layer on top of Nucleus Documents. Maintain your document accessibility and add regulatory compliance, standards based folder structures and improved visibility of eTMF information.

Automatic Metadata

Configure your own automated metadata schema to ensure consistency across your eTMF.

Document Versioning and History

Track document versions over time to identify any changes and who has made them.

At a glance Document Listing and Exports

Export all artefacts within your eTMF using the built in mechanism for export and archive at any point in your study. Users can generate eTMF Exchange Mechanism Standard compliant exports including all current and previous versions, metadata and audit trails using the eTMF options feature.

Find information fast

Powerful full content search, backed by Microsoft Azure, allows you to search inside your TMF documents and tags to quickly find the content you are looking for.

Remote monitoring and document review

Allow users access to individual sections of the eTMF for document review or to allow instant access for remote monitoring.

Reference Model Support

TMF Reference Model structures are supported out of the box to enable fast study startup. Customize and adjust the structure to your exact requirements for required or supplementary documents.

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