Electronic Trial Master File

MAESTRO eTMF delivers real-time inspection readiness with intuitive document management, automated workflows, and comprehensive compliance controls designed for modern clinical research.

eTMF Module

Complete Document Management

MAESTRO's eTMF module transforms clinical trial documentation from a compliance burden into a strategic asset. With intuitive organization, powerful search capabilities, and automated quality checks, our platform ensures your trial documentation is complete, accurate, and inspection-ready at all times.

Document Management

  • Comprehensive DIA Reference Model support with full TMF structure
  • Intelligent document classification and auto-filing
  • Robust version control and document history tracking
  • Advanced search with metadata, full-text, and OCR capabilities
  • Customizable templates for consistent document creation

Regulatory Compliance

  • 21 CFR Part 11 compliant electronic signatures
  • Automated audit trails with complete user action logging
  • Real-time compliance validations and gap analysis
  • Configurable retention policies with secure archiving
  • Inspection-ready reporting with one-click access

Workflow Automation

  • Automated document request workflows with tracking
  • Configurable review and approval processes
  • Intelligent document expiry notifications and renewals
  • Automated quality control checks and validations
  • Site-specific document collection and management

Inspection Readiness

  • Real-time completeness tracking with visual dashboards
  • Automated identification of missing or expiring documents
  • Inspection-ready views with custom access portals
  • Comprehensive metrics and analytics on documentation status
  • Remote inspector access with secure, read-only permissions

Document Exchange

  • Secure portal for sponsor-site document exchange
  • Automated notifications for document requests
  • Bulk document upload and download capabilities
  • Multi-party collaborative document review
  • Comprehensive chain of custody tracking

Interoperability

  • Open API for third-party system integration
  • EHR/EDC document connector for streamlined data flow
  • Automated import from email and shared drives
  • Standardized document exchange (CDISC, HL7 FHIR)
  • CRO and vendor collaboration tools

eTMF Benefits

99%

Inspection Readiness

Maintain perpetual inspection readiness with real-time completeness tracking.

75%

Reduced Documentation Time

Slash document processing time with intelligent automation and workflows.

60%

Fewer Document Queries

Automated quality controls catch issues before they become audit findings.

100%

Regulatory Compliance

Meet global regulatory requirements with built-in compliance controls.

Seamless Integration

MAESTRO eTMF integrates seamlessly with other MAESTRO modules to provide a unified trial documentation experience:

eTMF + CTMS

Documents automatically link to their corresponding studies, sites, and activities, creating a complete trial context with bi-directional navigation.

eTMF + QMS

Quality events trigger appropriate documentation updates, ensuring consistency between quality processes and trial documentation.

eTMF + Workflows

Customizable workflows automate document collection, review, and approval processes with role-based assignments and deadlines.

eTMF + AI Agents

AI-powered document classification, metadata extraction, and quality checks dramatically reduce manual document processing time.

Success Story: Mid-size Biotech

"MAESTRO eTMF transformed our documentation from our biggest regulatory concern to our greatest confidence. We passed our recent FDA inspection with zero findings."

A mid-sized biotech company was struggling with documentation completeness across their Phase II oncology trials. With documents scattered across multiple systems and sites, they faced critical inspection readiness issues that put their timeline at risk.

After implementing MAESTRO eTMF, they consolidated all trial documentation into a single, compliant system with automated workflows for document collection and review. The real-time completeness tracking immediately identified critical gaps, allowing them to remediate issues before they became inspection findings.

Within 60 days of implementation, their documentation completeness improved from 68% to 99%, and they successfully passed a subsequent regulatory inspection with zero documentation findings – a first in the company's history.

Schedule a Demo

See how MAESTRO eTMF can transform your clinical documentation. Schedule a personalized demo with our team to explore the platform's capabilities and discuss your specific needs.

Join organizations achieving real-time inspection readiness, automated document workflows, and complete compliance control—all while saving hours daily per team member.

Book Your Discovery Call