“This guidance assists sponsors of clinical investigations in developing RBx – Risk-Based Study Execution strategies and plans for investigational studies of  medical products, including human drug and biological products, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the quality of clinical trial data by focussing sponsor oversight on the most important aspects of study conduct and reporting.

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 FDA Guidance for Industry document, 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 full FDA  Guidance for Industry 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.

FDA Guidance for Industry