Wayne, PA – CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has further expanded its Late Phase work in Japan by entering into two new partnerships with global top 20 pharmaceutical companies. The collaborations mark the latest success for CluePoints in the region, with its centralized statistical monitoring (CSM) platform having already been used by the Nagoya University School of Medicine for an eight-year Phase III Stomach Cancer Adjuvant Multi-Institutional Group Trial (SAMIT).
The new studies will see both sponsors using CluePoints’ solution to check data quality and integrity across all investigative sites and patients. By using advanced statistical methodologies to identify any anomalies or outliers in data, the platform works to target monitoring to the sites and patients where it is most needed. The CluePoints’ solution was used during the SAMIT trial once the committee had recognized that traditional approaches to quality control may not be fully effective. It provided reassurances that the clinical trial protocol had been consistently followed across participating centres.
“Our continued growth in Japan builds on CluePoints’ commitment to becoming the ‘go-to’ Risk-Based Monitoring (RBM) technology in this key market for both regional and global clinical trials,” comments François Torche, CEO, CluePoints. “We are already undertaking analyses of Phase III studies in Japan with mid-tier pharmaceutical companies, improving clinical data quality and contributing to the reduction in the overall risk associated with sponsors’ regulatory submissions.”
Keen to build on its presence in the region, CluePoints will host its next RBM Roadshow in Tokyo in November. The event will explore a day-in-the-life of a team responsible for successfully planning and executing RBM, review the growing evidence in favour of the approach and reveal how delegates can lead their organizations’ RBM journey. The event will take place at the Tokyo Belle Salle, Sumitomofudousan Chiyoda on November 9, 2017, from 1:30 – 4:30pm. For more information and to register, please visit https://lp.cluepoints.com/risk-based-monitoring-roadshow-registration
In support of the company’s wider long-term growth strategy across the Asia-Pacific region, CluePoints is undertaking ‘knowledge transfer’ initiatives on behalf of large pharmaceutical companies in both China and Singapore to equip teams of central data scientists to use its software to analyze hundreds of clinical trials. This will drive significant cost and efficiency savings and increase data quality and integrity in line with the new ICH E6 R2 guidance.
CluePoints® is a Risk-Based Monitoring and Central Statistical Monitoring solution that has been designed and perfected over the last 15 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 ICH, FDA and EMA, CluePoints® is deployed to support traditional on-site monitoring, medical review 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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