It ensures the quality, timeliness, and completeness of the TMF, providing real-time access to clinical documentation throughout the trial lifecycle.

Key Features

• Centralized Document Management:
  • Single Repository: Stores all trial-related documents in one place, making it easy to manage and retrieve information.
  • Version Control: Maintains a clear audit trail of document versions and changes.
  • Automated Classification: Uses the TMF Bot to automatically classify and file documents, ensuring accuracy and efficiency.
• Inspection Readiness:
  • Real-Time Access: Provides sponsors and CROs with real-time access to clinical documentation, ensuring ongoing inspection readiness.
  • Expected Document Lists (EDLs): Manages completeness and timeliness through EDLs, ensuring all required documents are present and up-to-date.
• Collaboration and Compliance:
  • Remote Access: Enables remote monitoring and collaboration between sponsors, CROs, and sites.
  • Compliance: Supports 21 CFR Part 11 compliance with electronic signatures and audit trails.
• Efficiency and Automation:
  • TMF Bot: Automates document classification and metadata setting, reducing manual effort and increasing accuracy.
  • Milestone Templates: Allows bulk addition of milestones to studies, ensuring consistency across studies and sites.
• Integration and Connectivity:
  • Medidata CTMS Integration: Syncs data between Medidata CTMS and Vault eTMF, ensuring consistency and reducing manual data entry.
  • RIM to Clinical Operations Vault Connection: Automates data sharing between regulatory and clinical operations, streamlining processes.
• User-Friendly Interface:
  • TMF Viewer: Provides a dynamic view of TMF content, allowing users to switch between multiple hierarchies and easily navigate documents.
  • Quality Issue Tracking: Tracks and manages quality issues within the TMF, ensuring timely resolution and compliance.

Benefits

• Enhanced Efficiency: Automates and streamlines TMF management processes, reducing administrative burden and speeding up document processing.
• Improved Compliance: Ensures all documentation meets regulatory standards, reducing the risk of non-compliance.
• Better Collaboration: Facilitates real-time collaboration and transparency between all stakeholders involved in the clinical trial.
• Increased Visibility: Provides comprehensive insights into TMF completeness and quality, enabling proactive management and continuous improvement.