Electronic Trial Master File

The Electronic Trial Master File (eTMF) by Cloudbyz is a cloud-based solution designed to manage all clinical trial documents, including files, images, and information, in a centralized repository. It facilitates the digital capture, management, sharing, and storage of essential trial documents, ensuring they are always inspection-ready. This system provides real-time visibility for Contract Research Organizations (CROs), sponsors, monitors, and other stakeholders involved in clinical trials.

Product Features:

• Standard and Custom TMF Reference Models: Utilize the latest DIA reference model or customize your own. Modify folder structures as needed for specific study requirements.
• Full TMF Search: Efficiently find and retrieve documents using a robust search engine that works with both file names and metadata. Customize list views with various filters.
• Review & QC Workflow: Streamline document review processes with built-in workflows. Assign statuses like "approved" or "flagged" and receive notifications at each review step.
• Drag & Drop Upload: Easily upload files with drag-and-drop functionality, either directly to destination folders or into a holding area for additional QC checks.
• Automated and Configurable Metadata: Customize and store extensive metadata to enhance document identification and retrieval. Auto-populate metadata to streamline processes.
• Indexing and Audit Trails: Quickly create, classify, and index documents while maintaining a comprehensive audit trail for validation and security.
• ISF Reconciliation: Connect sponsor and site operations seamlessly, allowing sites to upload essential documents directly into the system.
• Chat, Email, and System Notifications: Facilitate cross-functional communication and ensure timely task completion with rule-based notifications.
• eTMF Reports and Dashboards: Monitor critical metrics such as quality and timeliness through customizable reports and dashboards. Automate tracking and alerts as needed.
• Customizable Role-Based Access: Manage user access at various levels, granting specific permissions to monitors, auditors, and internal users.
• Automations: Enhance productivity with features like automatic folder structure generation, document auto-naming, and metadata auto-population.
• Data Security: Built on the secure Salesforce cloud platform, offering high levels of data security and granular user access management.
• Integration: Integrate with various clinical trial management systems to control processes from a single location, improving efficiency and documentation control.

The Cloudbyz eTMF system transforms paper-based trial master files into an electronic, cloud-based model, available alongside Cloudbyz CTMS. It supports CROs, sponsors, and sites in managing clinical trial master files with multi-gadget configurability.