Cloudbyz eTMF Demo | DIA & Custom Folder Structure with 1-Click! | Archival | Report Subscription

This video provides an in-depth demonstration of the Cloudbyz electronic Trial Master File (eTMF) solution, focusing on its capabilities for streamlining clinical document management, ensuring regulatory compliance, and providing real-time study metrics. The system is presented as a unified platform built on the Salesforce cloud, designed to help eTMF managers, sponsors, and CROs maintain oversight of clinical studies and manage the high volume of essential documents required for regulatory audits. The core value proposition highlighted is the ability to simplify complex tasks like folder creation, metadata entry, document archival, and compliance tracking.

The demonstration begins by showcasing the system's intuitive homepage and navigation, emphasizing quick access to core entities like accounts, contacts, clinical studies, and sites. A key feature is the ability to instantly generate the standardized DIA (Drug Information Association) folder structure or utilize a custom structure with a single click, providing flexibility while maintaining organization standards. The system supports granular site access control, allowing administrators to expose specific areas, such as a "holding area" or investigator portal, where sites can upload documents for initial Quality Control (QC) review by the sponsor or CRO team before final placement in the TMF. This workflow is crucial for maintaining TMF quality and completeness.

A significant focus of the demo is on reducing manual data entry errors and improving efficiency. The platform allows users to view the document content side-by-side with the metadata entry fields on a single screen, eliminating the need to toggle between windows. This feature is positioned as a direct solution to decreasing the probability of metadata entry mistakes. Furthermore, the system supports defined approval processes, tracks approval history, and maintains a comprehensive metadata audit trail, addressing critical regulatory requirements such as 21 CFR Part 11. For study closure, the system facilitates simple archival by allowing users to select a folder level and download the entire content for export with a few clicks.

Finally, the demonstration emphasizes the system’s robust reporting and business intelligence capabilities. The platform provides visual dashboards and metrics that display the "health" of the eTMF at various folder levels. Managers can leverage pre-built reports to identify critical issues, such as documents with missing metadata or documents nearing expiration across all active studies. To ensure proactive compliance, the system offers a report subscription feature, allowing users to set conditions (e.g., weekly delivery) for receiving automated reports detailing expiring documents, thereby ensuring crucial deadlines are met and the TMF remains inspection-ready.

Key Takeaways: • Standardized and Custom Folder Creation: The eTMF solution supports the instant creation of the industry-standard DIA folder structure or allows for the implementation of custom folder structures, providing necessary flexibility while ensuring adherence to established TMF methodologies. • Enhanced Data Entry Efficiency and Accuracy: By enabling side-by-side viewing of the document content and its associated metadata fields, the system significantly reduces the chance of manual data entry errors, which is a common pitfall in TMF management and a risk to data integrity. • Controlled Site Access via Investigator Portal: The platform allows for controlled access to specific TMF sections, such as a "holding area," enabling sites to drop documents for initial review by the QC team before they are formally filed, ensuring document quality control prior to inclusion in the official TMF. • Robust Regulatory Compliance Features: The system includes essential compliance tools, such as defined document approval processes, detailed approval history tracking, and a comprehensive metadata audit trail, which are vital for meeting GxP and 21 CFR Part 11 requirements during regulatory inspections. • Real-Time TMF Health Metrics: Users can access visual dashboards and metrics that provide immediate insight into the health and completeness of the eTMF at the study and folder level, allowing managers to quickly pinpoint areas requiring attention or remediation. • Simplified Study Archival Process: At the conclusion of a study, the system facilitates easy archival by providing a function to download the entire folder content at any selected level, streamlining the process of preparing the TMF for long-term storage or transfer. • Proactive Compliance Reporting via Subscriptions: The ability to set up automated report subscriptions is a critical feature for proactive compliance, allowing managers to receive scheduled reports (e.g., weekly) detailing documents that are missing metadata or nearing expiration, preventing critical regulatory lapses. • Salesforce Cloud Foundation: The Cloudbyz eTMF is built on the Salesforce cloud platform, suggesting potential benefits in terms of scalability, security, and ease of integration with other enterprise systems commonly used in commercial and clinical operations (e.g., Veeva CRM).

Tools/Resources Mentioned:

• Cloudbyz eTMF (electronic Trial Master File)
• Salesforce Cloud Platform

Key Concepts:

• eTMF (electronic Trial Master File): A digital repository for essential clinical trial documents that individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced. Maintaining an accurate and complete eTMF is a regulatory requirement.
• DIA Structure (Drug Information Association): A standardized, widely adopted organizational structure for the TMF, ensuring consistency across different clinical trials and organizations.
• Metadata Audit Trail: A chronological record of all changes made to the data fields (metadata) associated with a document, crucial for demonstrating data integrity and compliance with regulations like 21 CFR Part 11.
• QC Process (Quality Control): The procedures implemented to review documents uploaded to the TMF to ensure they are accurate, complete, legible, and appropriately filed before being accepted as final TMF documents.