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Centralized Data Surveillance for Respiratory

Process-Oriented Analytics for Risk-based Monitoring

In respiratory clinical trials, identifying investigative sites that are proficient in respiratory data collection and consistently produce high quality data is critical for success. Sites produce low quality data due to lack of training, collection inconsistencies and in some instances, site misconduct. Centralized Data Surveillance addresses these challenges by identifying and solving data quality issues early on in centralized spirometry and other cardiopulmonary tests.

Centralized Data Surveillance for Respiratory trials begins with an upfront analysis of your study protocol by ERT’s Project Management, Education and Training, and Pulmonary Specialist Overreader teams to identify potential areas of risk 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
  • Spirometry and Pulmonary Function Testing Endpoint Trending
  • Optional Review of Respiratory Outliers and Risks Between ERT and StudyTeams
  • Optional Corrective and Intervention Plan for Respiratory Sites

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:

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

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