31 October 2016
Cambridge, MA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Centralized Statistical Monitoring (CSM) solutions for clinical trials, today announced a new Data Quality Oversight service, RADARTM, aimed at helping sponsors achieve a data-driven understanding of risks to an inspection-ready level. As regulators insist that sponsors adopt more comprehensive quality oversight methodologies, this new service looks to move away from antiquated processes to a more rigorous statistical approach to operational quality assurance including preparation for site inspections.
CluePoints’ RADAR™ service harnesses the advanced statistical interrogation of clinical and operational study data to identify investigative sites with a preponderance of anomalous, missing or inconsistent data that may require inspection readiness action. The company’s Data Analysts conduct a comprehensive assessment using the software to identify these higher-risk sites and data which may have escaped detection previously. This rigorous approach is anticipated to benefit sponsor submissions by identifying anomalous sites along with the nature and extent of potential data issues.
“The launch of our ground-breaking RADAR service marks another exciting development in data quality-driven risk analysis. This unsupervised, independent solution will help clinical research organizations to move away from existing time-consuming, approximate and costly procedures” comments Franҫois Torche, CEO, CluePoints. “It analyzes data trends over time to help comply with regulators’ standards, ensuring data quality and ultimately mitigating risks and improving the safety of patients.”
Inspiring confidence throughout the process, this service is an extremely cost-effective alternative to traditional site inspection readiness planning. It provides a report that ranks the most anomalous sites, identifies areas of risk across site and patient data and anticipates where regulators might also target their site inspections. Companies are adopting the RADAR service to use across Clinical Operations, and now in particular for Clinical Quality, Auditing, and Inspection Readiness. Sponsors can access all these benefits through CluePoints’ outsourced service approach, and alternatively can obtain the CluePoints’ platform for internal, enterprise level adoption.
For further information on CluePoints’ solutions, please visit www.CluePoints.com.
CluePoints® is a Risk-Based Monitoring and 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
+44 (0) 7703 532 749