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Centralized Data Surveillance for Electronic Clinical Outcomes Assessments (eCOA)

Process-Oriented Analytics for Risk-based Monitoring

Centralized Data Surveillance solutions provide a proactive and predictive view of eCOA data at the endpoint, patient, site, study and program level, with a broad range of analysis from program-level comparisons to the narrow discovery of patient outcome deviations and aberrations. Preconfigured, customized algorithms facilitate trending and outliers while ad-hoc reports permit private data exploration and visualization. With centralized data surveillance, study teams can monitor and assess:

  • Predictive and Actual Compliance Metrics per Patient Visit, Assessment, and Site
  • Patient, Clinician and Caregiver Inter- and Intra- Rater Scoring Trends
  • Patient Adverse Effects and Rescue Medicine Patterns
  • Patient Eligibility and Adjudication
  • Deviations and Outliers in Patient Outcomes, across Assessments
  • Investigative Site Trends and Comparative Performance
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How It Works

Centralized Data Surveillance for eCOA begins with an extensive protocol or program review and analysis by an ERT Clinical Scientist. This investigation will identify potential areas of risk and signal detection for clinically significant outcomes, data integrity and protocol compliance. Based on this review, the ERT Clinical Scientist will customize a surveillance package with analytics, reports and interactive dashboard components:

  • Cross-Study Analytics & Visualizations
  • Real-time 3rd Party Data Integration from EDC, IWR, Labs
  • Proprietary Risk-Based Monitoring Analytics across all study components

How It Works

Centralized Data Surveillance for eCOA begins with an extensive protocol or program review and analysis by an ERT Clinical Scientist. This investigation will identify potential areas of risk and signal detection for clinically significant outcomes, data integrity and protocol compliance. Based on this review, the ERT Clinical Scientist will customize a surveillance package with analytics, reports and interactive dashboard components:

  • Cross-Study Analytics & Visualizations
  • Real-time 3rd Party Data Integration from EDC, IWR, Labs
  • Proprietary Risk-Based Monitoring Analytics across all study components

Learn More About Centralized Surveillance

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