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Risk Based-Monitoring

Leverage data-driven insights to uncover and manage key trial risks

The Revvity Risk-Based Monitoring Solution provides analytics and visualizations to focus resources on high impact trial risks to ensure effective risk and data management

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Signals for Risk-Based Monitoring

The Revvity Risk-Based Monitoring Solution provides a number of advantages in deploying a risk-based approach to clinical trial oversight. 

  • Adaptive Risk Model A flexible approach that includes key risk indicator (KRI) definitions, thresholds, weightings, and recommended actions 
  • Advanced and Predictive Analytics Leverage historical site data to dynamically calculate tolerance limits and thresholds and adjust KRI weightings as trials evolve. 
  • Alignment with TransCelerate’s RBM initiative RACT (Risk Assessment and Categorization Tool), traffic light indicators and focus on critical data and processes 
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Respond to risk

Respond to risk

Risk-based monitoring addresses forces that have been adding data complexity to clinical trials including:  

  • Adoption of risk-based approaches to quality in the ICH guidelines 
  • Increased focus on vendor oversight and traceability in decision making
  • Advent of precision medicine and value-based treatment schemes 
  • Rising use of real-world data to generate product evidence and  data in clinical trials
  • Safety and efficacy beyond randomized clinical trials 
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Closed-Loop Workflow in One System

Closed-Loop Workflow in One System

  • Trigger recommended actions 
  • Report actions back into the system 
  • Assess the historical impact of the actions 
  • Build insights back into the risk model 
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Leverage Your Historical Data

Leverage Your Historical Data

  • Assess the impact of recommended actions over time 
  • Predict risks and make smarter site selections
  • Establish risk tolerance thresholds
  • Improve protocol and study design quality
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Signals Data Processing

Scale the Delivery of Spotfire Analytics

Spotfire is an easy-to-use analytics platform that helps clinical researchers quickly uncover insights from clinical trial data.  Spotfire easily accesses analysis ready data in Signals Clinical to enable self-service clinical analytics at biopharmas and CROs of all sizes globally.

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Leverage Data-Driven Insights

Leverage Data-Driven Insights

Revvity’s Risk-Based Monitoring (RBM) solution lets clinical monitors easily navigate from high-level overview data to specific data points from multiple source systems. Powered by Spotfire® analytics and visualization software, the RBM solution quickly identifies and tracks actions for high-risk sites, reduces complexity by supporting multiple trial designs and data sources, and optimizes monitoring by using adaptive risk models that apply to historical study data.

Reducing Time and Risk

Reducing Time and Risk

The RBM solution is proven to accelerate the monitoring process, driving down time, process steps, and costs.

Reduction in:

  • Number of major protocol violations – 20-50 percent
  • Underperforming sites – up to 30 percent
  • In time to database lock – 10-30 percent 
  • Number of source system integrations – 30-50 percent 
  • IT infrastructure and support costs – up to 67 percent
Monitor High-Risk Sites

Monitor High-Risk Sites

To identify high-risk sites, the RBM solution provides easy-to-use, dynamic visualizations and analytics that are powered by validated statistical models. Actions are automatically recommended based on persona-driven workflows, while vendor oversight is easily managed via dashboards.

Optimize Monitoring

Optimize Monitoring

A risk-based approach optimizes monitoring by using adaptive risk models that are applied to historical study data. Fully adjustable thresholds, weighting, and actions improve the risk model while predictive analytics leverage historical data to make smarter site selection decisions, and ultimately improve study/protocol design. The solution also enables a complete audit trail.

Related Workflows: 

Medical/Clinical Data Review

Facilitate review of active study data to monitor safety, efficacy, and data quality across the entire portfolio.

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Pharmacovigilance

Visual analytics to accelerate the response to safety issues while facilitating regulatory compliance

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Resources

Request a demo, or contact our experts to learn how Clinical Analytics can solve your risk-based monitoring challenges.

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