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PerkinElmer Risk-Based Monitoring Solution

Source: PerkinElmer, Inc.

PerkinElmer Risk-Based Monitoring Solution

The PerkinElmer Risk-Based Monitoring Solution is the most effective way to leverage data-driven insights to optimize site performance while improving 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.

Benefits of Risk-Based Monitoring

  • Quickly identify and track actions for high risk sites
  • Reduce complexity by supporting multiple trial designs and data sources
  • Optimize monitoring using adaptive risk models applied to historical study data

Overview

Proven results reported by customers using PerkinElmer's Risk-Based Monitoring Solution

  • 20%-50% reduction in the number of major protocol violations
  • Up to 30% reduction in under-performing sites
  • 10%-30% reduction in the time to database lock
  • 30%-50% reduction in the number of source system integrations
  • Up to 67% reduction in IT infrastructure and support costs

Our RBM Solution:

  • An adaptive risk model approach that includes KRI definitions, thresholds, weightings, and recommended actions
  • Advanced and Predictive Analytics to arrive at statistically-justified tolerance limits and thresholds using historical data
  • Alignment with TransCelerate's RBM initiative
  • The RACT (Risk Assess­ment and Cat­e­go­riza­tion Tool), traffic light indicators and focus on critical data and processes
  • Closed-Loop Workflow in one system (the following 4 lines are sub-bullets to this line)
    • 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)

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