Engility eTMF

Engility® eTMF is a modern, scalable electronic Trial Master File platform developed by PHARMASEAL, designed to simplify and standardize clinical trial master file management for sponsors and CROs. Built specifically for clinical trials, it replaces paper-based and fragmented processes with a fully digital eTMF, improving efficiency, transparency, and regulatory compliance across the entire trial lifecycle.

A defining characteristic of Engility® eTMF is its seamless unification with Engility® CTMS, enabling organizations to centralize, organize, and control their electronic TMF within a single, secure platform. This integration reduces data duplication, eliminates complex third-party integrations, and increases data reusability through unified master-data management.

Key Benefits

• Unification: Master-data management unified with Engility® CTMS reduces data duplication and increases data reusability across the organization.
• Efficiency: Streamlined document management processes reduce manual effort and enable rapid access to critical trial documentation.
• Compliance: Ensures adherence to regulatory requirements and industry standards, maintaining audit-readiness at all times and minimizing risk.
• Collaboration: Centralized access to real-time trial information fosters seamless collaboration among stakeholders, facilitating better decision-making and accelerated outcomes.
• Security: Sensitive trial data is safeguarded through robust encryption protocols and role-based access controls, ensuring confidentiality and data integrity.
• Scalability: A flexible, scalable architecture adapts effortlessly to evolving trial needs and grows alongside an organization's trial pipeline.
• Insights: Comprehensive reporting and analytics capabilities provide valuable insights into trial performance and document status, enabling proactive management and optimization.

Platform Features

• TMF Reference Model: Built on the industry-standard CDISC TMF Reference Model, providing a structured framework for managing the electronic trial master file consistently across global trials.
• Template Management: Create and manage global and study-specific eTMF plan templates to standardize filing and metadata organization across studies and the wider organization.
• Document Placeholders: Track expected documentation using placeholders within the eTMF to ensure completeness throughout the trial.
• Document Inbox: A single, streamlined queue where records can be staged in preparation for review and filing, simplifying the ingestion process.
• Comprehensive Search: Quickly retrieve content using both metadata-driven and in-content search capabilities across the entire electronic trial master file.
• Dashboards and Reporting: Dynamic dashboards and advanced analytics enable monitoring of document status, compliance metrics, and overall trial performance.
• Access Management: Fine-grained user permissions are maintained across the eTMF using a global, study, country, and site-specific security model to support security and compliance requirements.
• Audit Trail: A complete, inspection-ready audit trail of all document actions and revisions is preserved within the trial master file at all times.

Engility® eTMF is purpose-built to support faster trials, improved oversight, and confident regulatory inspections. By moving organizations away from paper-based processes and fragmented systems, it delivers a compliant, modern digital trial master file solution suited to the demands of today's clinical development environment.