“Good Clinical Practice (GCP), is a set of internationally recognised ethical and scientific standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.

CluePoints is committed to helping sponsors execute clinical trials in line with recommendations set out in the applicable regulatory guidance documents. Our products utilize statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data, both during and after study conduct. Aligned with guidance in the EMA Risk-Based Quality Management in Clinical Trials paper, 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.

Check out the full EMA Risk-Based Monitoring reflection paper (to the right), to discover how the CluePoints platform can help your organization work in line with monitoring recommendations. Alternatively, contact us for a personalized demo.

EMA Risk Based Quality Management Document