The latest version of the Good Clinical Practice (GCP) quality standard insists that Sponsors implement a Risk-Based Approach to Study Execution, a methodology that CluePoints calls RBx. This goes far beyond the previous guidance from ICH, FDA, EMA which all advocate the adoption of Risk-Based Monitoring to address all areas of Quality Management, not just monitoring.

The areas of the guidance which address the new Risk-Based Quality Management and CRO Oversight requirements can be found in the following sections of ICH E6 R2:

ICH E6 (R2) Guidance Document

CluePoints is committed to helping sponsors and CROs execute clinical trials in line with these recommendations. Our products utilize statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data, both during and after study conduct. CluePoints is deployed to support traditional monitoring and data management and can be implemented as the ultimate engine to drive RBx – Risk-Based Study Execution.

CluePoints has all the necessary software modules to ensure compliance with ICH E6 R2. It will continue to develop the software to ensure that customers of all size can deploy a fit-fur-purpose Quality Risk Management System to assess, control, manage and document risk throughout all stages of clinical trial conduct.

Check out the ICH (E6) Addendum document (to the right), to discover how the CluePoints platform can help your organization work in line with the recommendations. Alternatively, contact us for a personalized demo.