Clinion eTMF (Electronic Trial Master File) is a digital solution designed to manage, organize, and store essential clinical trial documentation throughout the lifecycle of a clinical study. The eTMF system ensures compliance with regulatory requirements while improving operational efficiency by replacing traditional paper-based methods with a secure, centralized electronic repository.
Key Features of Clinion eTMF
- Document Management:
- Centralized storage for all trial-related documents.
- Categorization based on the Trial Master File (TMF) Reference Model.
- Easy search, retrieval, and version control of documents.
- Compliance and Audit Readiness:
- Ensures adherence to ICH-GCP, FDA 21 CFR Part 11, and other regulatory standards.
- Maintains a detailed audit trail for all document changes and actions.
- Supports inspection readiness with quick access to required documentation.
- Role-Based Access Control:
- Provides secure, role-based access to ensure only authorized personnel can view or edit specific documents.
- Tracks user activities to enhance data security.
- Workflow Automation:
- Automates document review, approval, and signature workflows.
- Sends notifications and reminders for pending actions.
- Ensures timely updates and compliance with study timelines.
- Integration Capabilities:
- Seamlessly integrates with other Clinion solutions such as CTMS, EDC, and RTSM.
- Enables data and document flow across systems to eliminate duplication.
- Reporting and Dashboards:
- Real-time reporting on document status, completeness, and compliance metrics.
- Customizable dashboards for stakeholders to monitor TMF progress.
