It provides end-to-end study management and monitoring capabilities for both insourced and outsourced trials, ensuring efficient and compliant trial execution.

Key Features

• Centralized Study Management:
  • Single Source of Truth: Unifies data and documentation across clinical operations, providing a single source of truth.
  • Real-Time Dashboards: Offers dashboards and reports that track key performance indicators, including enrollment and milestones, with drill-down capabilities for detailed insights.
• Monitoring and Reporting:
  • Automated Monitoring Visit Reports: Supports automation and dynamic question branching for monitoring visit reports, which are automatically filed within Vault eTMF.
  • Issue and Protocol Deviation Management: Logs issues and protocol deviations, routing them through resolution workflows to ensure timely closure.
• Integration and Connectivity:
  • Vault EDC Integration: Connects with Vault EDC to support enrollment, monitoring, payments, and navigation to casebooks directly from within Vault CTMS.
  • Veeva CRM Synchronization: Synchronizes investigator interactions with Veeva CRM, providing a 360-degree view of trial activities.
• 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 and efficiency.
• Compliance and Inspection Readiness:
  • 21 CFR Part 11 Compliance: Supports electronic signatures and audit trails to meet regulatory requirements.
  • Expected Document Lists (EDLs): Manages completeness and timeliness through EDLs, ensuring all required documents are present and up-to-date.
• User-Friendly Interface:
  • Intuitive Navigation: Provides role-based dashboards and intuitive navigation to enhance user experience.
  • Quality Issue Tracking: Tracks and manages quality issues within the CTMS, ensuring timely resolution and compliance.

Benefits

• Enhanced Productivity: Equips study teams with tools to manage trials more efficiently, reducing time spent on monitoring and administrative tasks.
• Improved Decision-Making: Enables proactive decision-making with real-time visibility into trial status and performance metrics.
• Better Collaboration: Facilitates improved collaboration between sponsors, CROs, and sites through real-time data sharing and communication.
• Increased Compliance: Ensures all trial documentation and processes meet regulatory standards, reducing the risk of non-compliance.
• Streamlined Operations: Automates and streamlines trial management processes, enhancing overall trial efficiency and reducing costs.