CluePoints, a provider of centralized statistical monitoring (CSM) and risk-based monitoring (RBM) solutions for clinical trials, has partnered with the Metrics Champion Consortium (MCC), an association dedicated to the development of standardized performance metrics to improve clinical trials. Drawing on the company’s vast expertise in RBM, CluePoints will work with the consortium to help drive collaboration in the development of a standardized framework for Central Monitoring, including identification and definition of what is included, who should be involved, and how best to manage the process.
“We are excited to have the opportunity to lead such an important initiative for the Metrics Champion Consortium,” said Steve Young, senior vice president of U.S. Operations at CluePoints. “The industry is finally beginning to move forward to large scale adoption of RBM, yet there remain many questions on the topic of Central Monitoring, and so we look forward to driving clear guidance and standards for this critical component of RBM success.”
The Metrics Champion Consortium has created the Central Monitoring work group to help facilitate the exchange of knowledge and expertise in standardization of clinical risk management. Known for organizing work groups with the intention of providing metrics for the clinical trials industry, MCC has engaged CluePoints to work with them to more clearly define what Central Monitoring is for the industry.
Linda Sullivan, co-founder and president of Metrics Champion Consortium, said, “Results from our recent Risk-based Approaches to Monitoring Industry Survey show an increasing number of organizations use/plan to use central monitoring approaches in the next 12 months as compared to two years ago. This new MCC work group will bring sponsors, CROs, central & core labs, consultants and IT system vendors together to explore what key risk indicators, performance metrics and data should be included in central monitoring, what analytic approaches should be used to gain valuable insights and how organizations should use the insights to ensure patient safety and improve data quality. CluePoints’ experience with centralized monitoring and risk-based monitoring make the company ideally placed to bring the community together to share insights and align thinking to established, shared global standards.”