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Centralized Data Surveillance for Cardiac Safety

Process-Oriented Analytics for Risk-Based Monitoring

Central Data Surveillance for Cardiac Safety includes an upfront analysis of your study protocol by ERT’s Science & Consulting team to identify potential areas of risk and signal detection for clinically significant outcomes, data integrity and protocol compliance. Based on our initial assessment, ERT will make recommendations and collaborate with study teams to initiate a comprehensive surveillance package that can include the following analytics, reports and interactive dashboards:

  • Site Performance & Quality
  • Subject Outlier Trending & Analysis
  • Endpoint Trending

In addition to the above standard packages, ERT works with study teams to design, develop and implement protocol/program specific surveillance packages that can include, but are not limited to the following:

  • Cross-study Analytics & Visualizations
  • Real-time 3rd Party Data Integration (EDC, IWR, Labs, etc.)
  • Standard and configurable RBM Analytics across all ERT product lines
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