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eTMF

Record management and secure access to clinical trial documentation with customizable, role-based workflows.

Solution by Viedoc
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Overview

Viedoc eTMF is an electronic Trial Master File record management system designed for clinical trial teams that require secure, role-based access to trial documentation around the clock. The platform supports studies of varying complexity and offers customization options to match specific study requirements.

The system is part of the broader Viedoc product suite, which includes Viedoc Admin for study management, Viedoc Designer for study design, and Viedoc TMF for compliant document access and management.

Core Capabilities

  • Role-based, site-level access controls to ensure only authorized users can view or manage specific documents
  • 24/7 access to all trial documentation through a secure platform
  • Customizable structure to accommodate studies of varying size and complexity
  • Fast setup supported by an intuitive interface
  • Straightforward record management with extensive configuration options

Oversight and Compliance Features

  • Status indicators to keep users informed of document and study progress
  • Advanced filtering to locate relevant records quickly
  • Complete audit trail to track all document activity and changes
  • Compliant document access management aligned with regulatory expectations for trial master files

Collaboration and Access Management

  • Site-level permissions ensure that users access only the information relevant to their role
  • Role-based access supports both compliance requirements and operational efficiency across distributed teams
  • Designed to support collaboration among sponsors, sites, and other study stakeholders

Viedoc eTMF is offered as part of the Viedoc platform, which also covers electronic data capture and study design. The platform is rated 4.5 out of 5 on G2 based on over 200 reviews, with users noting ease of use, customizability, and responsive customer support as notable characteristics.

Meta

Domain
Clinical Trial Management
Subdomain
Clinical Trial Management Systems (CTMS) & eTMF
Software type(s)
Record-Keeping System
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechCROPharma
Development stage(s)
Clinical
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic ProfessionalIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP