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Risk-Based Monitoring (RBM)

We offer an innovative approach for risk-based monitoring that leads to a reduction in the number of physical clinical site inspections while preserving clinical trial data quality and ensuring patient safety.

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With our solution for risk-based monitoring, the effort spent on complete source-data verification can be significantly reduced. The resulting savings (in both time and costs) allows for better data analysis and better protection of subjects without multiplying costs.


  • Adaptive Risk Model
    • A flexible approach that includes KRI definitions, thresholds, weightings, and recommended actions
  • Advanced and Predictive Analytics
    • Analyze historical data to arrive at statistically-justified tolerance limits and thresholds
  • Alignment with TransCelerate's RBM initiative
    • RACT (Risk Assess­ment and Cat­e­go­riza­tion Tool), traffic light indicators and focus on critical data and processes
  • Closed-Loop Workflow in one system
    • Trigger recommended actions
    • Follow up on the actions
    • Assess the historical impact of the actions
    • Build insights back into the risk model
  • Powered by TIBCO Spotfire® (intuitive, interactive visualizations, data agnostic platform, advanced and predictive analytics)