RBx – A Risk-Based Approach to Study Execution

CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 20 years and now ensures compliance with the obligations of ICH E6 R2 for Sponsors and CROs alike. It’s cloud-based software employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the ICHFDA and EMA, CluePoints® is deployed to support traditional on-site monitoring, medical review, quality risk management and to drive a Risk-Based Monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of data management and clinical monitoring and a significant reduction in overall regulatory submission risk.

Our Vision

CluePoints’ vision is to be THE provider of enabling technologies for ICH E6 R2 compliance, RBx – Risk-Based Study Execution, and Overall Data Quality Oversight within clinical trials. The company strives to improve the quality of clinical research by employing intelligent statistical techniques to interrogate operational and clinical data and support companies in taking corrective action and producing error-free submissions. In future, CluePoints will deploy new and ground-breaking techniques such as machine learning and predictive analytics to fully exploit the potential of this advanced data interrogation in clinical research.

Our Values

Passion: CluePoints’ Founder, Marc Buyse, has been passionate about the detection of fraud in clinical trials for over two decades and his vision has extended to the wider identification of anomalous data. Like Marc, the current Management Team and all members of the CluePoints family evangelise about the use of automated statistical techniques to interrogate clinical and operational data sets, inspiring Sponsors, CROs and Partners alike to address the challenges and opportunities of ICH E6 (R2).

Innovation: CluePoints strives to deliver software that will help improve clinical data quality and integrity while adhering to both regulatory guidance and the principles of practical implementation.

Accuracy: We are committed to providing the most powerful information to our clients and partners, allowing them to make accurate and timely decisions about their clinical trial conduct.

Integrity: Our company uses its expertise and know-how to improve its solutions and ensure that sponsors get the best out of our software and experience value in everything we do.