CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, has announced that the U.S. Patent and Trademark Office has granted a Notice of Allowance for Application No. 13/452,338, a patent which covers the company's 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," said 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."