case Study

Risk-Based Monitoring

Client:

Confidential Client

Company Revenue:

$22.9B

Company Industry:

Pharmaceuticals

Employees:

‍40,600+

Opportunity

  • Create an adaptive approach to clinical trial monitoring that directs monitoring focus and activities to the evolving areas of greatest need and have the most potential to impact patient safety and data quality
  • Develop a means to track and view all clinical trials
  • Ensure attainment of overarching data quality and integrity while maintaining the safety of patients

Solution

  • Build an application to onboard new clinical trial studies with data structure additions and/or modifications, allow central monitors to run analytics for assigned studies, and integrate information into the Data Mart
  • Integrate disparate data sources and formats
  • Develop an analytics capability
  • Create advanced analytics at the individual study level in the form of advanced data visualizations

Impact

  • Ability to monitor plans developed based on assigned risk level of trial and critical data points
  • Enabled dynamic defining and adjustment of risk thresholds while automating reporting
  • Provided monitoring of all clinical trials holistically
  • Empowered risk-level assessment of trials based on program, trial, IP and sites
  • Capable of viewing electronic source data

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‍40,600+