eTMF

Clinevo Electronic Trial Master File (eTMF) is a web-based system for organizing, storing, and managing documents, images, and other digital content generated during clinical trials. It is designed for pharmaceutical companies, biotech organizations, CROs, site personnel, and external vendors who require a structured, regulation-aligned approach to trial master file management.

The system includes a built-in DIA reference model and is designed to meet multiple regulatory frameworks, including 21 CFR Part 11, Annex 11, GxP, and GDPR. It can function as a dedicated eTMF or as a general document management system for clinical trials.

Core Compliance and Document Control Features

• Inbuilt DIA TMF reference model with the option for organizations to define sponsor-specific TMF structures
• Document lifecycle management covering authoring, review, electronic signature, and approval workflows
• Automated version control with check-in and check-out functionality
• Audit trails to record document activity and changes
• Change controls and system validation support
• Digital content archiving with security and access control

File Planning and Document Tracking

• Allows creation of file and study plans with milestones defined at the study, country, and site levels
• Tracks document status against the file plan and monitors TMF compliance at every level
• Live tracking of missing documents based on the established file plan
• Advanced analytics to track completeness, quality, timeliness, and overall TMF compliance for a study

Document Upload and Indexing

• Supports bulk and quick upload of large numbers of documents using drag-and-drop functionality
• Provides dynamic indexing options for uploaded documents
• Integrates with CDMS and CTMS systems to retrieve study, site, and patient information and dynamically generate directory structures

Collaboration and Accessibility

• Allows external parties to be invited to upload and collaborate on documents in a controlled manner
• Accessible via internet or intranet through IE, Chrome, and Firefox browsers on any device
• Designed for fast user adoption, with training reported to be completable within a few hours for business teams, CROs, site personnel, and external vendors

Deployment and Integration

• Cloud-based deployment intended to reduce infrastructure requirements and manual processes
• Integrates with external CDMS and CTMS systems
• Trusted by life sciences, pharmaceutical, biotech, and CRO clients across the USA, UK, Europe, Korea, Japan, China, and India
• Includes automated compliance checks and audit trail tools to support adherence to regulatory guidelines
• Vendor provides implementation support, training, and ongoing assistance