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Engility® eTMF The Intelligent Electronic Trial Master File Platform

Engility® eTMF is a modern, scalable electronic trial master file (eTMF) system designed to simplify and standardize clinical trial master file management. Unified seamlessly with Engility® CTMS, our solution enables sponsors and CROs to centralize, organize, and control their electronic TMF within a single, secure platform.

Built specifically for clinical trials, Engility® eTMF replaces paper-based processes with a fully digital eTMF, improving efficiency, transparency, and regulatory compliance across the trial lifecycle.

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Benefits of Engility® eTMF

Unification

Master-data management unified with Engility® CTMS reduces data duplication, complex integrations and increases data reusability.

Efficiency

Streamline document management processes, reducing manual efforts and enabling rapid access to critical trial documentation.

Compliance

Ensure adherence to regulatory requirements and industry standards, minimizing risks and ensuring audit-readiness at all times.

Collaboration

Foster seamless collaboration among stakeholders with centralized access to real-time trial information, facilitating better decision-making and accelerated outcomes.

Security

Safeguard sensitive trial data with robust security measures, including encryption protocols and role-based access controls, ensuring confidentiality and integrity.

Scalability

Adapt to evolving trial needs effortlessly with a scalable and flexible eTMF solution that grows alongside your trial pipeline.

Insights

Gain valuable insights into trial performance and document status through comprehensive reporting and analytics capabilities, enabling proactive management and optimization.

Features

TMF Reference Model

Built on the industry-standard CDISC TMF Reference Model, Engility® eTMF provides a structured framework for managing your electronic trial master file consistently across global trials.

Template Management

Create and manage global and study-specific electronic trial master file plan templates to standardize filing and metadata organization across your organization and across studies.

Document Placeholders

Ensure completeness by tracking expected documentation using placeholders within your electronic trial master file.

Document Inbox

The document inbox within the eTMF system provides a single, streamlined queue where records can be staged in preparation for review and filing

Comprehensive Search

Quickly retrieve content using metadata-driven and in-content search across your electronic trial master file.

Dashboards and Reporting

Monitor document status, compliance metrics, and trial performance using dynamic dashboards and advanced analytics.

Access Management

Maintain security and compliance with fine-grained user permissions across your electronic TMF, leveraging Engility’s global, study, country and site-specific security model.

Audit Trail

Preserve a complete, inspection-ready audit trail of all document actions and revisions within your trial master file.

Transform Your Clinical Trials

Move away from paper-based processes and fragmented systems. Engility® eTMF delivers a modern, compliant digital trial master file solution that supports faster trials, improved oversight, and confident inspections.
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