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Document Process Management
CIO Bulletin
15 October, 2025
Datatrak eTMF speeds up clinical efficiency internationally and enables document management, visibility, compliance, and collaboration effects of trials.
Datatrak International, the world-recognized Contract Research Organization (CRO), claimed that it deployed its Datatrak eTMF solution to an international CRO to streamline trial master file management and enhance the efficiency in managing documents that constitute various studies.
Datatrak eTMF was chosen by the CRO as it provides a smooth linkage to Datatrak eSource dashboards, through which all workflows, permissions, and documentation can be centrally managed. The VP of Clinical Operations of the company affirms that the switch has made the working process much more efficient and less costly but Part 11 compliant.
Datatrak eTMF offers a single system in document management that leads to the elimination of redundancies associated with the deployment of individual EDC and TMF systems. Clinical teams are given improved visibility and quicker review cycles with the capability to manipulate multi-site studies, which are complicated.
Datatrak eTMF facilitates end-to-end management of documents to CROs and sponsors in support of EDC, RTSM, CTMS, eTMF, eConsent, and ePRO/eCOA as part of the Datatrak eSource Technology Platform, which uses Fountayn.
The Datatrak document management system, which is an all-in-one document management system, lowers the costs of technologies and enhances cooperation among international study teams in the US, the European Union, and Japan. Such a combined method enables clinical teams to be more concerned with the results of a trial and at the same time guarantee precise documentation of the study throughout the study history.