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Risk-Based Monitoring (RBM)

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

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 include

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

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Part Number RBM

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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
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