GENIUS RIBAM™ > QUALITY RISK MONITORING & MANAGEMENT

The essence of the Quality Risk Monitoring & Management is that study sites are monitored and managed based on what has been detected from those parameters or risk indicators which have the most potential to impact patient safety and data quality. Genius RIBAM™ moves away from the traditional approach of frequent on-site visits and 100 percent source data verification (SDV) toward a combination of activities, including centralized data analytics and monitoring. This information is obtained and analyzed by means of automated real-time reports and algorithms for site performance and quality.

According to the new GCPs Addendum ICH E6 (R2), June 14th, 2017

The sponsor should implement a system to manage quality throughout the design, conduct, recording, evaluation, reporting and archiving of clinical trials. The quality management system should use a risk-based approach.

BENEFITS OF GENIUS RIBAM™

  • Improve quality: uncover holistic insights ongoing assessment and data surveillance
  • Enhance patient safety: detect signals earlier and share data faster to get to analysis-ready data sooner
  • Increase site effectiveness: leverage seamless technology to improve site communications and drive focus on patients
  • Drive efficiency: centralize monitoring and operational support to standardize delivery and resolve queries faster
  • Reduce costs: allocate resources effectively by focusing on high risk areas with data analytics

Common Principles Underlying Genius RIBAM™

  • Early and ongoing risk assessment
  • Building Quality by Design (QbD) into the study
  • Identifying and tracking critical processes and critical data
  • Use of risk indicators and thresholds
  • Partial source data verification
  • Use of centralized, off-site, and adaptive monitoring while the study is underway
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