18 May 2015
Cambridge, MA – CluePoints, a leading provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced that the United States Patent and Trademark Office has granted a Notice of Allowance for Application No. 13/452,338, a patent which covers the company’s award-winning SMART engine. The patent provides broad coverage for CluePoints’ proprietary methodology that supports a risk-based approach to data monitoring in clinical trials.
The SMART engine is central to CluePoints’ CSM solution which uses statistical methodology to identify unexpected or unusual patterns in clinical trial databases. The approach uses a large number of statistical tests and scoring algorithms to identify investigative centers whose data are inconsistent with data from other centers taking part in the same trial. The newly patented method is proven to be sensitive to a wide-range of errors in data, including inaccuracies due to equipment mis-calibration, lack of staff training and non-adherence to a protocol, as well as data falsification and fabrication. As such, CluePoints’ solution can support risk-based monitoring and quality assurance strategies, ensuring corrective measures and monitoring efforts are focused on errant sites efficiently, resulting in both reduced regulatory submission risk and costs.
“The Notice of Allowance covering the SMART engine strengthens CluePoints’ position in delivering our unique methodology to the U.S market”, comments Franҫois Torche, CEO, CluePoints. “As a one-of-its-kind solution, the patent not only provides our clients with assurance that they are working with the only method of its type, but ensures that we are firmly at the forefront of CSM. We believe that the protection of our intellectual property through this patent puts the company in a valuable position to benefit from the rich promise of the solution within the risk-based-monitoring space.”
For further information on CluePoints, please visit www.CluePoints.com
CluePoints® is a Central Statistical Monitoring solution that has been designed and perfected over the last 10 years. It 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 FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring 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 on-site monitoring and a significant reduction in overall regulatory submission risk.
Patrick Hughes – Chief Commercial Officer, CluePoints
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