CluePoints has entered into an enterprise agreement with Japanese drug development organization, ONO Pharmaceutical. The agreement will utilize the CluePoints centralized statistical monitoring (CSM) platform to drive its RBM strategy over a four-year period.
CluePoints and ONO will 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.
“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,” Patrick Hughes, Chief Commercial Officer at CluePoints said. “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.”