eTMF Connect Demo | Accelerating Clinical Study and Site Start up

This video provides a demonstration of eTMF Connect, a solution designed to accelerate the clinical study and site startup process by leveraging pre-existing trial information and automating traditionally manual tasks. The core purpose of the system is to centralize and standardize clinical records, allowing both sponsors and Contract Research Organizations (CROs) to efficiently manage and access critical documentation in real-time. The demonstration focuses on the study management feature, highlighting how users like "David" can organize, manage, and create new studies and sites with minimal effort, effectively eliminating the cumbersome paper-based processes often associated with clinical trial initiation.

The demonstration walks through the user experience, beginning with navigating to the study management area where a full overview of current studies, sites, and staff is available. The system utilizes accordion-style drop-downs to provide quick access to high-level study and site information. A key feature showcased is the creation of a new site using a dynamic form. This form incorporates "intelligent lookups" and dynamic elements that connect the entire study structure. As the user selects fields in drop-down menus (e.g., selecting the study), associated fields are automatically populated with relevant options, significantly reducing the potential for human error and ensuring data consistency across the trial setup. This automation is central to the system's value proposition of accelerating startup phases.

Once the site creation form is completed and submitted, the site startup is immediately initiated. The system then transitions seamlessly into site-level document management. The video highlights three distinct methods for document ingestion, catering to different user workflows: uploading documents one at a time with individual classification, bulk uploading via drag-and-drop functionality from a desktop folder, or sending documents via email to an inbox for later classification. This flexibility in document handling ensures that study teams can quickly and compliantly populate the Electronic Trial Master File (eTMF) with essential site documents, further streamlining the transition from site setup to operational readiness.

The underlying methodology of eTMF Connect emphasizes standardization and centralization. By providing a single source of truth for clinical records, the solution ensures that all stakeholders—from sponsors to CROs—are working with the most current and compliant documentation. The focus on automating the initial setup phase, including the creation of sites and the initial population of the TMF, directly addresses a major bottleneck in clinical trials: the time-consuming and error-prone administrative burden of study initiation. This approach is critical for maintaining GxP compliance and ensuring audit readiness from the earliest stages of the clinical lifecycle.

Key Takeaways: • Automation of Study/Site Startup: The eTMF Connect solution leverages pre-existing clinical trial information to automate the creation and setup of new studies and sites, significantly accelerating the traditionally slow and manual study initiation phases. • Intelligent Data Consistency: The system utilizes dynamic forms with "intelligent lookups" where selecting one field automatically populates associated fields with relevant options, drastically minimizing data entry errors and ensuring high data quality across the clinical directory. • Centralized Clinical Records Management: The platform serves as a central hub for clinical records, enabling both sponsors and CROs to contribute, manage, and access essential clinical documents in real-time, which is crucial for collaborative trials. • Elimination of Paper Processes: The core benefit highlighted is the effective elimination of paper-based processes during study and site startup, moving all critical documentation and management tasks into a digital, compliant environment. • Flexible Document Ingestion: The system supports multiple methods for populating the eTMF with site-level documents, including single document uploads with classification, bulk drag-and-drop uploads, and email-to-inbox functionality for later classification, accommodating diverse user preferences. • Structured Information Management: The study management area provides a comprehensive overview of studies, sites, and staff, utilizing an accordion-style interface for quick access to high-level information, improving organizational efficiency for study teams. • Regulatory Compliance Foundation: As an eTMF vendor with over 10 years of experience, the solution inherently supports the necessary structure and audit trails required for GxP and 21 CFR Part 11 compliance, ensuring that clinical documentation is always inspection-ready. • Focus on User Workflow: The demonstration emphasizes a user-centric approach, showing how a user ("David") can quickly navigate, create, and manage complex clinical information through intuitive quicklinks and streamlined forms.

Tools/Resources Mentioned:

• eTMF Connect (Montrium)

Key Concepts:

• eTMF (Electronic Trial Master File): A system used by life sciences companies to manage, store, and archive the essential documents of a clinical trial in a digital format, ensuring regulatory compliance and audit readiness.
• Clinical Study and Site Start-up: The initial phase of a clinical trial involving regulatory approvals, site selection, contract negotiation, and the collection of essential documents before patient enrollment can begin.
• Intelligent Lookups: A feature in data entry forms where the system uses existing data relationships to suggest or automatically populate related fields, reducing manual input and improving data accuracy.
• Sponsors and CROs (Contract Research Organizations): The primary entities involved in clinical trials; sponsors fund the research, and CROs often manage the execution of the trial, requiring shared access to the eTMF.