DocuVault eTMF
Inspection-ready electronic Trial Master File management from day one. DocuVault delivers intelligent document filing, real-time completeness tracking, and regulatory-grade quality workflows — purpose-built to keep your TMF audit-ready at every stage of the clinical trial lifecycle.
Inspection Readiness, Automated
DocuVault is MTK Pharma's electronic Trial Master File platform, engineered to eliminate the compliance burden of traditional document management. Aligned with the DIA TMF Reference Model, DocuVault combines intelligent automation with rigorous quality controls to ensure every document is filed, reviewed, and retrievable exactly when regulators require it.
From first-patient-in through regulatory submission, DocuVault provides real-time visibility into TMF health across all sites, countries, and studies — enabling sponsors and CROs to move from reactive remediation to proactive oversight. Whether you manage a single study or a global portfolio, DocuVault scales to meet your document management needs while maintaining full regulatory compliance.
Purpose-Built for TMF Excellence
Six integrated capabilities work together to automate document filing, enforce quality standards, and deliver continuous inspection readiness across your entire trial portfolio.
TMF Reference Model
Pre-configured folder structure aligned with the DIA TMF Reference Model, providing a standardised yet flexible framework for organising your Trial Master File.
- DIA-aligned zone, section, and artefact hierarchy
- Customisable structure per study or programme
- Automatic version tracking for model updates
- Configurable artefact-level metadata schemas
Automated Filing
Intelligent document classification and rule-based filing dramatically reduce manual effort and eliminate misfiling errors across high-volume trial documentation.
- Intelligent document classification engine
- Automated metadata tagging and extraction
- Rule-based filing to correct TMF locations
- Bulk upload with drag-and-drop interface
Quality Review Workflows
Built-in quality control processes ensure every document meets regulatory standards before it is considered final within your Trial Master File.
- Configurable document review workflows
- QC checklists with pass/fail criteria
- Multi-level approval routing
- 21 CFR Part 11 compliant e-signatures
Completeness Dashboards
Real-time TMF health metrics provide continuous visibility into completeness, quality, and inspection readiness at study, country, and site level.
- TMF health scoring and trend analysis
- Completeness percentages by zone and section
- Missing document alerts and notifications
- Inspection readiness indicators
Full-Text Search
Advanced search capabilities allow teams to locate any document or content instantly, even within scanned images and legacy PDF documents.
- Advanced full-text search across all documents
- OCR-powered content indexing for scanned files
- Metadata filtering and faceted search
- Saved search templates and recent searches
Regulatory Export
Generate inspection-ready packages and regulatory authority submissions with a single click, eliminating weeks of manual preparation effort.
- One-click inspection package generation
- Regulatory authority secure sharing
- Archive-ready export in standard formats
- Configurable export templates and filters
Designed for Every Stakeholder
DocuVault delivers tailored value to every team involved in TMF management, from sponsor oversight through CRO operations to site-level document filing.
Sponsors
Maintain complete oversight of your TMF across all studies with real-time dashboards and inspection readiness metrics that provide regulatory confidence.
- Continuous inspection readiness visibility
- Real-time TMF oversight across all studies
- Regulatory confidence through validated workflows
- Portfolio-level TMF health reporting
CROs
Manage multiple sponsor TMFs within a single platform, with standardised filing conventions and automated workflows that drive operational efficiency.
- Multi-sponsor TMF management
- Standardised filing conventions
- Automated workflows reducing manual effort
- Role-based access across sponsor programmes
Site Teams
Simplified document submission with guided filing, intuitive upload, and automatic version control that minimise the administrative burden on busy site staff.
- Easy document upload with guided filing
- Intuitive interface requiring minimal training
- Automatic version control and history
- Real-time status tracking for submissions
Connected to Your Clinical Ecosystem
DocuVault integrates natively with the MTK Pharma clinical technology platform, enabling automated document flow and eliminating the manual effort of cross-system document management. Bi-directional data exchange ensures your TMF is always current and complete.
EDC Platform
Automatic filing of eCRF completion records, edit check documentation, and database lock artefacts directly into the TMF.
CTMS
Bi-directional integration with trial management for site activation documents, monitoring reports, and milestone artefacts.
eConsent
Signed informed consent forms and version updates automatically filed into the correct TMF zone with complete audit trail.
rSDV
Source documents uploaded for remote verification are cross-referenced and linked to corresponding TMF artefacts.
Why Choose MTK for eTMF
DocuVault combines deep regulatory expertise with modern technology to deliver an eTMF platform that is powerful, compliant, and remarkably easy to use.
Inspection-Ready
Built for regulatory scrutiny from the ground up. Every workflow, audit trail, and quality control is designed to satisfy GCP inspectors and regulatory authorities.
Rapid Deployment
Pre-configured TMF structures and reusable templates enable study setup in days rather than weeks, accelerating your path to first patient in.
Expert Support
Dedicated TMF specialists provide onboarding, configuration guidance, and ongoing support to ensure your team maximises the platform's capabilities.
Cloud-Native
Enterprise-grade cloud infrastructure with 99.9% uptime, automated backups, disaster recovery, and global data centre availability for worldwide trials.
From Upload to Inspection-Ready
DocuVault manages the complete document lifecycle within your Trial Master File, from initial upload through quality review to final archival. Every step is tracked, validated, and audit-trailed to ensure your TMF meets the highest regulatory standards.
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Intelligent Upload
Drag-and-drop or bulk upload with automatic document classification, metadata extraction, and filing to the correct TMF location.
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Quality Review
Configurable QC workflows with checklists, approval routing, rejection handling, and electronic signature capture for document finalisation.
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Completeness Monitoring
Real-time dashboards track TMF health at zone, section, and artefact level with automated alerts for missing or overdue documents.
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Archival & Export
Generate inspection packages, create regulatory authority sharing links, and produce archive-ready exports in compliant formats.
Regulatory-Grade Document Security
DocuVault is built on a foundation of regulatory compliance and enterprise security. Every aspect of the platform — from data encryption to access control — is designed to protect the integrity and confidentiality of your Trial Master File.
Full Audit Trail
21 CFR Part 11 compliant audit trail recording every action, access, and modification with timestamped operator identity.
Role-Based Access
Granular, role-based permissions with multi-factor authentication, session controls, and IP-based access restrictions.
Data Encryption
AES-256 encryption at rest and TLS 1.3 in transit for all documents, metadata, and system communications.
GDPR Compliant
Full GDPR compliance with data minimisation, pseudonymisation capabilities, and cross-border transfer safeguards.
See DocuVault in Action
Schedule a personalised demonstration to discover how DocuVault can transform your TMF management, deliver continuous inspection readiness, and reduce the administrative burden on your clinical operations team.