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What is Risk-Based Management and Monitoring (RBQM) software?

Risk-Based Management and Monitoring (RBQM) software is used to identify, assess, and manage risks in clinical trials. It helps teams focus monitoring efforts on the areas with the highest potential impact on patient safety and data quality. The software uses real-time data and predefined rules to flag issues early and guide corrective actions.

RBQM systems support centralized monitoring by collecting and analyzing site performance, data trends, and protocol deviations. The software helps prioritize monitoring visits, manage risk plans, and document actions taken. It reduces the need for routine site visits and supports a more targeted, efficient approach to trial oversight.

 

All Risk Based Management and Monitoring

Top benefits of RBQM software for clinical trials:

  • Early risk detection: The system flags data issues, delays, or safety concerns as they happen.
  • Smarter monitoring: Resources are focused on high-risk sites and processes.
  • Improved data quality: The software highlights trends and outliers for faster review.
  • Fewer on-site visits: Centralized tools reduce the need for frequent travel to research sites.
  • Real-time analytics: Dashboards and reports show current trial risks and site performance.
  • Regulatory compliance: RBQM features help meet industry standards for risk-based monitoring.
  • Clear documentation: All risk assessments and actions are logged in the system.
  • Flexible planning: Risk plans can be adjusted during the trial based on live data.

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