“The Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting data trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.”

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 ICH (E6), CluePoints is deployed to support traditional monitoring and data management and can be implemented as the ultimate engine to drive Risk-Based Monitoring.

Check out the ICH (E6) Addendum document (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.

ICH E6(R2) Addendum Document