CluePoints, a leading provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has entered into a significant enterprise agreement with leading Japanese drug development organization, ONO Pharmaceutical Co., Ltd.
The agreement sees ONO utilizing the CluePoints centralized statistical monitoring (CSM) platform to drive its RBM strategy over a four-year period and firmly strengthens CluePoints’ established presence in the Asia Pacific market.
Following a successful pilot study in 2017, ONO, who are actively pursuing research and development of drugs for cancer, auto-immune disease and neurological disease, recognized the impressive cost and resource efficiencies that can be achieved by using advanced statistical methodologies to identify the sites and patients where monitoring is most needed.
CluePoints and ONO will now continue to work in close partnership over the next four years to build on the success of the pilot program. Experts from CluePoints in Japan will deliver on-site training and provide ongoing support to the ONO team to ensure the adoption of the RBM approach delivers the best possible results.
Since the introduction of the ICH E6 (R2) addendum in 2016, the industry has seen an increase in the implementation of a variety of RBM methodologies and technologies, however, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) is yet to release any specific regional guidance on its use. As one of the first companies in its market to embrace an RBM approach, before it is even required by regulators, this partnership demonstrates ONO’s innovative and proactive philosophy and clearly positions the company as an innovator in the region.
Patrick Hughes, Chief Commercial Officer at CluePoints comments: “The enterprise agreement with ONO represents a significant step forward for CluePoints, and further cements our position as the ‘go-to’ Risk-Based Monitoring (RBM) provider in the Asia Pacific region. It’s an honor for us to work with such a forward-thinking company, who are embracing the global regulatory changes and recognizing the power of RBM before the Japanese PMDA has formally mandated the approach. We’re confident that through our continued collaborative approach, our relationship with ONO will prosper and we are very much looking forward to working with the team over the next four years and beyond.”
ONO comments. “We are delighted to announce our partnership with CluePoints, an industry-leading company that supports the practical implementation of RBM techniques in clinical trials. It is vital that technology and software developers and pharmaceutical companies work together to ensure new technologies meet the needs of today’s trials. Integrating CluePoints software into our trials will enable us to achieve positive results in terms of significant cost and efficiency savings as well as giving us peace of mind that the data is accurate and conforms to industry regulations.”
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.
About Ono Pharmaceutical Co.,Ltd.
In keeping with its philosophy of “Dedicated to Man’s Fight against Disease and Pain” Ono Pharmaceutical Co. Ltd. has always strived to achieve its goal of serving as an R&D-oriented global specialty pharmaceuticals, aiming to develop innovative and globally recognized drugs. For additional information please go to www.ono.co.jp