Complete document management.
Transform clinical trial documentation from compliance burden to strategic asset — intuitive, searchable, 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.
Inspection readiness
Maintain perpetual inspection readiness with real-time completeness tracking.
Reduced documentation time
Slash document processing time with intelligent automation and workflows.
Fewer document queries
Automated quality controls catch issues before they become audit findings.
Regulatory compliance
Meet global regulatory requirements with built-in compliance controls.
Seamless integration with MAESTRO.
MAESTRO eTMF connects natively with CTMS, QMS, Workflow and AI Agents — one 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 + Workflow
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.