electronic trial master file (eTMF)

Maximize Efficiency

Streamline the trial process by facilitating document filing in accordance with the latest reference model. By improving the searchability and traceability of study documents, clinical teams can save critical time and improve internal processes.

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Gather Insights

View planned and actual milestones at any given point during the study. eTMFs often offer reports and dashboards, which aid in identifying potential problems early on and tracking trial progress.

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Enhance Collaboration

Sponsors, CROs, and site staff are seldom based in the same location. Teams spread across different time zones can leverage built-in tools such as workflows and document editors to collaborate both asynchronously and simultaneously. A centralized eTMF reduces reliance on multiple communication methods out of the system; instead, instructions and comments provided within the eTMF are considered the source of truth. These capabilities cut down on miscommunications and rework.

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Improve Inspection Readiness

Ensure documents are present and filed correctly in accordance with the latest regulations. If a sponsor has dozens of sites at various stages within the same trial, the eTMF can be updated contemporaneously, which provides a clearer picture which documents are outstanding. Read Less

Control TMF Security

TMFs often contain sensitive information, some of which must be blinded for study personnel. eTMFs provide more advanced access permissions than traditional shared drives, which protects patients and the integrity of the trial data. Read Less