TMF Platform

Comprehensive Trial Master File system for efficient document management, regulatory compliance, and seamless collaboration across clinical trial teams.

TMF Platform Features

Our TMF platform provides comprehensive document management capabilities for clinical trial compliance and efficiency.

Document Management

Comprehensive document management system with automated workflows and version control.

Version Control

Advanced version control with complete audit trails and change tracking capabilities.

Audit Trail

Complete audit trail functionality with detailed logging and compliance reporting.

Regulatory Compliance

Built-in regulatory compliance features for FDA, EMA, and other global requirements.

Cloud Storage

Secure cloud-based storage with backup and disaster recovery capabilities.

Collaboration Tools

Advanced collaboration features for multi-site document management and review.

Document Categories

Comprehensive document management for all clinical trial documentation

Protocol Documents

Clinical Protocol
Protocol Amendments
Investigator Brochure
Statistical Analysis Plan

Regulatory Documents

Ethics Committee Approvals
Regulatory Submissions
Safety Reports
Study Reports

Site Documents

Site Contracts
CVs & Licenses
Training Records
Delegation Logs

Monitoring Documents

Monitoring Reports
Source Data Verification
Query Logs
Deviation Reports

Regulatory Compliance

Built-in compliance with global regulatory standards

ICH GCP

International Council for Harmonisation Good Clinical Practice

FDA 21 CFR Part 11

Electronic Records and Electronic Signatures

EMA GCP

European Medicines Agency Good Clinical Practice

ISO 14155

Clinical investigation of medical devices

Platform Benefits

75%
Faster Document Access
100%
Compliance Assurance
50%
Reduced Administrative Time

Streamline Your Trial Documentation

Experience efficient document management and regulatory compliance with our comprehensive TMF platform.