It helps sponsors manage the sharing of study registrations and results disclosures with public registries, ensuring compliance with global regulations and improving operational efficiency.

Key Features

• Centralized Disclosure Management:
  • Unified Platform: Manages the entire disclosure process, including capture, review, workflow, approval, reporting, and XML generation and submission.
  • Data Integration: Leverages data from Vault eTMF, Vault CTMS, and Vault Study Startup, eliminating the need for third-party integrations and manual data entry.
• Automated Processes:
  • Pre-Configured Rules: Uses pre-configured registry rules to ensure compliance with regulatory requirements.
  • Automated Alerts: Provides automated alerts for changes in study data and milestones, prompting users to take necessary actions.
• Real-Time Visibility:
  • Dashboards and Reports: Offers real-time visibility into global submission status, operational progress, and key metrics through comprehensive dashboards and reports.
  • Audit Trails: Maintains detailed audit trails for all disclosure activities, ensuring transparency and compliance.
• Efficiency and Agility:
  • Document Authoring: Enhances productivity with real-time submission document authoring, point-and-click configuration, and approval workflows.
  • Speed Submissions: Accelerates submissions with pre-configured rules, country intelligence, and automated alerts for registry updates.
• Compliance and Oversight:
  • Data Validation: Improves accuracy and transparency with built-in data validation, version control, and audit trails.
  • Inspection Readiness: Ensures ongoing inspection readiness by automatically filing disclosure documents in Vault eTMF.

Benefits

• Simplified Compliance: Streamlines the disclosure process, ensuring that all submissions meet regulatory standards and reducing the risk of non-compliance.
• Improved Efficiency: Automates and simplifies the management of clinical trial disclosures, reducing administrative burden and accelerating submission timelines.
• Enhanced Transparency: Provides real-time insights into the status of disclosures, improving oversight and decision-making.
• Unified Clinical Operations: Eliminates the need for third-party integrations by reusing data and documents across the Vault Clinical Operations suite.