eTMF

Clinion eTMF is an electronic Trial Master File platform designed for clinical trial teams, including sponsors and CROs, who need secure, validated, and regulatory-compliant document management across the full trial lifecycle. The system is built on the DIA TMF Reference Model and supports document storage, tracking, review workflows, and long-term archival from study setup through closeout.

The platform centralises all essential trial documentation — including protocols, investigator brochures, informed consent forms, IRB/IEC approvals, safety reports, monitoring visit logs, regulatory submissions, contracts, and correspondence — in a single, audit-ready environment that meets ICH GCP and 21 CFR Part 11 requirements.

Core Workflow Steps

1. Setup & Plan: Define user roles, select DIA or sponsor-specific standards, and create a detailed TMF file plan with critical milestones at the study, country, and site levels.
2. Conduct & Collaborate: Upload, index, and manage trial documents through a structured review and quality control workflow, with compliant electronic signatures for final approval.
3. Monitor & Oversee: Use real-time dashboards to track key metrics including eTMF completeness, timeliness, quality, and overall study compliance through detailed reports.
4. Lock & Archive: Securely lock the eTMF at trial completion to prevent further changes, and prepare final documentation for compliant long-term archival.

Key Features

• File Planning: Create detailed file plans and set critical milestones at the study, country, and site levels to align all stakeholders on eTMF expectations from day one.
• Live Tracking: The system automatically cross-references the file plan against actual documents, flagging missing or delayed files in real time so teams can take immediate corrective action.
• TMF Analytics: Dashboards provide insight into eTMF health, covering completeness, quality, and timeliness of documentation across the study.
• Flexible TMF Structures: Teams can use the prebuilt DIA reference model or configure a custom, sponsor-specific folder structure, metadata fields, naming conventions, and workflows to meet individual study requirements.
• Audit Trails: Automated alerts, real-time document tracking, and traceable records of TMF activity support inspection readiness at any point during the trial.
• Bulk Upload: Supports bulk document upload to reduce administrative burden and speed up document ingestion.

Compliance and Inspection Readiness

• Supports auditor review of document completeness, metadata accuracy, version control, and user access logs.
• Structured to meet ICH GCP and 21 CFR Part 11 requirements.
• Real-time dashboards and audit trails are available during regulatory inspections.
• Automated document tracking and smart reminders flag missing files, reducing manual reconciliation efforts and supporting faster study closeout.

Setup and Configuration

• Can be launched within a few days using a pre-built, DIA-compliant structure with smart defaults and customisable templates.
• Fully configurable for sponsors and CROs, allowing adjustments to folder structures, metadata fields, naming conventions, and workflows while maintaining compliance.

Clinion eTMF integrates with the broader Clinion clinical trial platform, which includes EDC, RTSM, eProtocol, eSource, eConsent, CTMS, CSR Automation, and ePRO modules. The platform is developed under Responsible AI principles covering accountability, transparency, privacy and security, reliability and safety, and fairness.