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 MetadataConfigure your own automated metadata schema to ensure consistency across your eTMF.
Document Versioning and HistoryTrack document versions over time to identify any changes and who has made them.
At a glance Document Listing and ExportsExport 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 fastPowerful 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 reviewAllow users access to individual sections of the eTMF for document review or to allow instant access for remote monitoring.
Reference Model SupportTMF 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.