eTMF Connect uses automation and built-in workflows to help scaling life sciences teams maintain inspection-ready documentation, start studies faster, and achieve real-time visibility into TMF completeness without the complexity of traditional eTMF systems.
Accelerate study startup with pre-configured TMF structures aligned to the TMF Reference Model, automated workflows, and reusable templates that eliminate repetitive setup work.
Get real-time visibility into TMF completeness, missing documents, and quality metrics through the eTMF Navigator, so you're always prepared for regulatory inspections.
Enable sites, CROs, and internal teams to contribute documentation seamlessly through email-to-TMF capabilities, and role-based access, supporting decentralized and hybrid trials.
Accelerate study startup with pre-configured TMF structures aligned to the TMF Reference Model, automated workflows, and reusable templates that eliminate repetitive setup work.
Get real-time visibility into TMF completeness, missing documents, and quality metrics through the eTMF Navigator, so you're always prepared for regulatory inspections.
Enable sites, CROs, and internal teams to contribute documentation seamlessly through email-to-TMF capabilities, and role-based access, supporting decentralized and hybrid trials.
The eTMF Navigator provides a visual overview of TMF completeness at the study, country, and site levels. Identify missing documents immediately and drag and drop files directly onto placeholders to update completeness in real-time.
Sites can email documents directly to study-specific inboxes where they're queued for indexing. Auto-filing based on document naming conventions means your team spends less time on administrative tasks and more time on critical study activities.
Real-time collaborative authoring, configurable workflows ensure all stakeholders can contribute effectively, whether they're at headquarters, global sites, or conducting remote visits. Maintain full compliance and control while enabling seamless collaboration.
Our team preps organizations for inspections, builds GCP-compliant frameworks, and helps define industry TMF standards. Get guidance from people who know what inspectors look for, not generic support.
Montrium protects customer data through rigorous security measures and compliance practices. All personnel with access to sensitive data are thoroughly vetted, maintain strict confidentiality, and receive ongoing security training. Testing protocols include penetration testing, vulnerability scanning, and code analysis. Cloud environments leverage Microsoft Azure's security features with data isolation, encryption in transit and at rest, and continuous monitoring aligned with SOC 2 standards.
FDA 21 CFR Part 11
Montrium systems meet FDA 21 CFR Part 11 requirements through secure user access, comprehensive audit trails, and electronic signatures that are uniquely assigned, securely linked to records, and protected against unauthorized use.
EudraLex Volume 4 Annex 11
Montrium products align with Annex 11 principles for computerized systems in GMP-regulated environments. Solutions support data integrity standards, provide secure audit trails, and enforce strict access controls through a risk-based validation approach.
SOC 2® Type I
Montrium successfully completed the AICPA SOC 2 Type I audit, confirming our information security practices meet SOC 2 standards for security.
Audit support
Montrium facilitates vendor qualification audits through transparent access to documentation and compliance evidence. We also support customers during regulatory inspections by supplying compliance documentation and responding promptly to inquiries.
ISO 9001:2015 QMS Alignment
Montrium's Quality Manual and procedural documents satisfy ISO 9001:2015 requirements for quality documentation, policy, and objectives.
GDPR
Montrium has implemented appropriate technical and security processes to ensure GDPR compliance.
See how eTMF Connect can help your team start studies faster, maintain inspection readiness, and scale clinical operations efficiently.
Find answers to common questions about eTMF Connect and its functionalities.
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In this first-of-its-kind white paper, Montrium's experts detail their new methodology for risk-based TMF management.
The CFO Pitch Guide is your playbook for executive conversations. Learn how to translate clinical tech benefits into CFO-ready messaging that drives clarity, confidence, and buy-in.
This TMF Toolkit is a curated collection of useful links, tools and resources compiled by TMF subject matter experts to support the TMF community. Bookmark it and check back often for new content and updates.
