Vault eTMF Product Demo

This video provides an in-depth demonstration of Veeva Vault eTMF, a cloud-based electronic trial master file system designed to streamline the management of clinical trial documentation for sponsors and Contract Research Organizations (CROs). The presenter walks through the system's capabilities, emphasizing its role in ensuring real-time access to critical documents, maintaining inspection readiness, enhancing visibility and oversight, and improving collaboration throughout the trial lifecycle—from setup and execution to archival. The core message revolves around eTMF being an active content management system rather than a mere repository, facilitating the full lifecycle management of documents with integrated workflows and, notably, leveraging artificial intelligence for automated classification.

The demonstration begins with an overview of the TMF homepage, showcasing its ability to display critical real-time information such as upcoming milestones, expected document details derived from templates, and dynamic charts visualizing completeness, timeliness, and quality metrics. Users can also view and act on outstanding tasks directly from this dashboard. The video then transitions to document viewing and management, illustrating how the TMF viewer allows users to browse through configured document type hierarchies for specific studies, countries, or sites. An alternative, more unstructured approach is presented through the document library tab, which offers robust searching and filtering capabilities to narrow down content.

A key highlight of the demo is the system's active content management approach. Unlike traditional repositories, Vault eTMF supports the entire document lifecycle, from authoring and review to quality control (QC) and final approval, with integrated workflows. The presenter demonstrates various methods for uploading documents, including a standard uploader, drag-and-drop functionality, and a bulk document inbox capable of handling up to 250 documents at once. A particularly innovative feature showcased is the "TMF bot," which utilizes artificial intelligence to automatically classify uploaded documents by applying type, subtype, and classification based on a trained model, significantly reducing manual effort and improving data consistency. The video concludes by highlighting Vault eTMF's standard reporting and dashboard capabilities, which offer out-of-the-box metrics and the flexibility for users to create custom reports to visualize specific key performance indicators, with dynamic drill-down functionality and export options.

Key Takeaways:

• Comprehensive Clinical Document Management: Veeva Vault eTMF functions as a robust, cloud-based electronic trial master file system, providing sponsors and CROs with real-time access to all clinical documentation throughout the entire trial lifecycle, from initial setup to archival.
• Ensuring Inspection Readiness: The system is specifically designed to maintain a constant state of inspection readiness by centralizing documentation, ensuring its completeness and quality, and providing clear audit trails and version control.
• Enhanced Visibility and Oversight: Users gain critical insights through the TMF homepage, which offers dynamic charts visualizing document completeness, timeliness, and quality, alongside upcoming milestones and expected document information, enabling proactive management.
• Active Content Lifecycle Management: Vault eTMF goes beyond being a simple document repository; it's an active content management system that supports the full lifecycle of eTMF documents, including authoring, review, quality control, and final approval, all managed through integrated life cycles and workflows.
• AI-Powered Document Classification: A standout feature is the "TMF bot," which leverages artificial intelligence to automatically classify uploaded documents (assigning type, subtype, and classification) based on a trained model, drastically reducing manual data entry and improving data accuracy and consistency.
• Streamlined Document Upload and Processing: The system offers multiple convenient ways to upload documents, including a standard uploader, drag-and-drop functionality, and a bulk document inbox that can process up to 250 documents simultaneously, enhancing operational efficiency.
• Flexible Document Viewing and Management: Users can navigate and manage documents through a structured TMF viewer with configurable document type hierarchies or utilize a more flexible document library tab with powerful searching and filtering capabilities.
• Robust Reporting and Business Intelligence: Vault eTMF provides standard out-of-the-box reports and dashboards for key TMF metrics, alongside the ability for users to create custom reports and dashboards, offering dynamic drill-down capabilities and export options for actionable insights.
• Improved Collaboration: The system is designed to foster better collaboration between sponsors and CROs by providing a centralized platform for document access, management, and workflow execution.
• Metadata Integration: Each document within the system is associated with comprehensive metadata, which enhances searchability, organization, and compliance tracking throughout its lifecycle.

Tools/Resources Mentioned:

• Veeva Vault eTMF
• TMF bot (AI component within Veeva Vault eTMF)

Key Concepts:

• Electronic Trial Master File (eTMF): A digital system for managing all essential documents of a clinical trial, ensuring compliance with regulatory requirements and facilitating trial oversight.
• Inspection Readiness: The state of having all necessary documentation and processes in place to successfully pass regulatory inspections at any given time.
• Active Content Management: A system that manages the entire lifecycle of content, from creation and review to approval, distribution, and archival, rather than just storing final versions.
• AI-powered Document Classification: The use of artificial intelligence algorithms to automatically categorize and tag documents based on their content, structure, and context, improving efficiency and accuracy.