eTMF Connect

eTMF Connect is an electronic Trial Master File (eTMF) software solution developed by Montrium, designed for scaling life sciences teams that need to maintain inspection-ready documentation without the complexity of traditional eTMF systems. By combining automation, built-in workflows, and real-time visibility tools, eTMF Connect helps clinical operations teams start studies faster, manage TMF completeness proactively, and support decentralized or hybrid trial models efficiently.

Trusted by thousands of TMF professionals globally, eTMF Connect is purpose-built for sponsors, CROs, and site teams across pharma, biotech, medical device, and non-profit organizations. The platform is designed to scale clinical operations without proportionally scaling workload, enabling teams to take on more studies and sites without adding significant time or cost.

Pre-Configured TMF Structures for Faster Study Startup

• Pre-configured TMF structures aligned to the TMF Reference Model eliminate repetitive setup work at study initiation.
• Automated workflows and reusable document templates accelerate study startup processes.
• Supports management of study TMF plans and document indexes.
• Includes a document template center and file plan to standardize filing practices across studies.

Inspection Readiness Monitoring

• The eTMF Navigator provides a visual overview of TMF completeness at the study, country, and site levels, enabling teams to identify missing documents immediately.
• Real-time access to TMF completeness reporting and quality metrics ensures teams are always prepared for regulatory inspections.
• Placeholders can be created for site staff to upload required content, making gaps visible and actionable.
• Dedicated reports help identify quality issues faster, allowing teams to catch problems before inspectors do.
• Files can be dragged and dropped directly onto placeholders to update completeness in real time.

Distributed Team Collaboration

• Sites, CROs, and internal teams can contribute documentation seamlessly through email-to-TMF capabilities, supporting decentralized and hybrid trial models.
• A study inbox allows batch emailing of site content, where documents are queued for indexing upon receipt.
• Auto-filing based on document naming conventions reduces administrative burden and frees teams for higher-value activities.
• Real-time collaborative authoring enables all stakeholders — at headquarters, global sites, or conducting remote visits — to contribute effectively.
• Role-based access controls and configurable workflows ensure compliance and security across all trial stakeholders.

Key Platform Differentiators

• The eTMF Navigator delivers instant visual insight into what needs attention across the TMF hierarchy.
• Filing bottlenecks are eliminated through study-specific inboxes and automated document routing.
• Montrium's team includes industry-leading experts who prepare organizations for inspections, build GCP-compliant frameworks, and help define industry TMF standards — providing guidance grounded in what inspectors actually look for.
• Customers have reported an estimated 80% increase in trial documentation efficiency after adopting eTMF Connect.

Security and Compliance

• Compliant with FDA 21 CFR Part 11, including secure user access, comprehensive audit trails, and electronic signatures uniquely assigned and securely linked to records.
• Aligned with EudraLex Volume 4 Annex 11 principles for computerized systems in GMP-regulated environments, supporting data integrity and strict access controls through a risk-based validation approach.
• SOC 2® Type I certified, confirming information security practices meet AICPA SOC 2 standards.
• ISO 9001:2015 QMS alignment for quality documentation, policy, and objectives.
• GDPR-compliant through appropriate technical and security processes.
• Cloud infrastructure leverages Microsoft Azure with data isolation, encryption in transit and at rest, and continuous monitoring.
• Security practices include penetration testing, vulnerability scanning, and code analysis, with thorough vetting and ongoing training for all personnel with access to sensitive data.
• Montrium facilitates vendor qualification audits and supports customers during regulatory inspections by supplying compliance documentation and responding promptly to inquiries.