Electronic Trial Master File (eTMF)

Cloudbyz Electronic Trial Master File (eTMF) is a cloud-based solution designed to centralize, manage, and streamline clinical trial documentation. Built to support regulatory compliance and operational efficiency, it enables sponsors, CROs, and research sites to digitally capture, store, and share essential trial documents in real time. The system ensures inspection readiness, enhances collaboration, and provides full visibility across the trial lifecycle.

Features

• Centralized Document Repository: Securely stores all clinical trial documents including protocols, consent forms, investigator brochures, and monitoring reports.
• Standard and Custom TMF Models: Supports DIA reference models and allows customization for study-specific TMF plans.
• Full TMF Search: Advanced search capabilities across file names and metadata with customizable filters.
• Review & QC Workflow: Built-in workflows for document review, approval, and quality control with status tracking and notifications.
• Drag & Drop Upload: Simplifies document uploads with flexible drag-and-drop functionality and holding areas for QC.
• Automated Metadata Management: Enables side-by-side viewing of content and metadata with auto-population and customization options.
• Audit Trails and Indexing: Tracks document history and indexing for compliance and traceability.
• Notifications: Real-time alerts via chat, email, and system messages to keep stakeholders informed.

Capabilities

• Inspection Readiness: Maintains organized, compliant documentation accessible for audits and inspections.
• Real-Time Collaboration: Facilitates seamless communication among study partners and stakeholders.
• Metadata-Driven Search: Enhances document retrieval speed and accuracy with dynamic metadata configurations.
• Role-Based Access Control: Ensures secure access and document handling based on user roles.
• Integration Flexibility: Can be integrated with CTMS, EDC, and other clinical systems for unified trial management.
• Scalability: Supports multi-site and global trials with flexible configuration options.

Benefits

• Improves operational efficiency and reduces manual document handling.
• Enhances regulatory compliance and audit readiness.
• Enables faster document retrieval and decision-making.
• Strengthens collaboration across sponsors, CROs, and sites.
• Reduces risk of misidentified or misplaced documents.
• Supports decentralized and remote trial operations.