CluePoints, a provider of Risk-Based Monitoring (RBM) and Data Quality Oversight solutions for clinical trials, has entered into an enterprise agreement with Japan’s ONO Pharmaceutical Co., Ltd. ONO will utilize CluePoints’ centralized statistical monitoring (CSM) platform for a four-year period to help create efficiencies by using advanced statistical methodologies to identify the sites and patients where monitoring is most needed.
 
CluePoints and ONO will now continue to work to build on the success of the pilot program initiated in 2017. CluePoints 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. This partnership represents ONO’s proactive approach as an innovator in the region.
 
Patrick Hughes, chief commercial officer at CluePoints said, “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 said, “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.”