Detecting Data Anomalies Suggestive of Fabrication or Misconduct for Monitoring Ongoing Trial

Music City Center 

A suite of complementary approaches are used across the data life cycle at patient, site, trial, portfolio levels to ensure the quality and data integrity of our clinical trials. These include elements of trial design, process, technology, analytics and automation. One important element is remote/centralized risk-based monitoring. This involves identification of critical data and processes, risk indicators and thresholds, and development and implementation of a monitoring plan to direct oversight efforts informed by known or emerging areas of risk.
This presentation is focused on using integrated data, statistical analytics and automation in the context of remote Risk Based Monitoring (rRBM) to increase the effectiveness of on-site monitoring by Clinical Research Associates (CRAs) of clinical sites participating in our trials. The objective is to enable more targeted monitoring that is informed and triggered by indicators of risk. The centralized approach using integrated data is expected to be more sensitive for earlier detection of sites with outlying performance and/or data, that may indicate issues with site conduct.

remote Risk Based Monitoring (rRBM)

Clinical Trial Oversight

earlier detection of site issue 

Biopharmaceutical Section