Anju -Model eTMF Master -Trial Master File (TMF) Software
Rapid Implementation Process
eTMF Master provides the DIA TMF Reference Model version 3.1 structure by default but lets you import and map other filing structures as well. Easily set up your study TMF folder structure via a quick and intuitive process. Drag and drop one or more files into the defined zones, sections and artifacts of the TMF, use step by step file upload, or integrate content from other systems
Seamless Integration
With eTMF Master, bring in data from your Clinical Trial Management System (CTMS), Electronic Data Capture (EDC) systems and more. With Anju`s adaptive platform, data can be brought in from any product in our own eClinical Suite or from 3rd party applications.
Actionable Insights
eTMF Master`s advanced visualization dashboards provide actionable insights for optimizing the TMF process. You have instant visibility into the health of your TMF via standard metrics, and your TMF is always inspection-ready.
eTMF Master provides a secure, regulatory-compliant environment for storing your TMF. Role-based access can be granted at the client, compound, protocol, country or site levels, as well as for specific zones, sections or artifacts.
eTMF`s dashboards provide actionable insights into the TMF process. Dashboards are available for tracking and ensuring that your TMF is complete and up-to-date, as well as for metrics on the status of documents.
eTMF Master is fully compliant with all applicable regulations. Among other features, access is fully controlled and monitored, all activities are captured in secure audit logs, and electronic signatures are used for all document approvals.
With eTMF Master, search your TMF based on content, attributes or properties at the file, folder, trial or enterprise level. Customize and save searches, follow hyperlinks into the content retrieved, and export search results as reports.
eTMF Master provides easy upload and mapping of content to the TMF, including such features as moving and re-indexing, soft-deletes, printing, and export of the TMF. Placeholders provide guidance into what documents are expected and help measure the completeness of your TMF.
With eTMF Master`s workflow management capabilities for your document classification and QC review process to ensure that your documents are compliant and that you have what you need to recreate your study if needed. With eTMF Master you can easily classify, review and approve documents, assign to team members, and send relevant notifications and alerts.