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Harvest Integrated Research Organization (HiRO), a Shanghai-based Clinical Research Organization, has collaborated with CluePoints, to provide Risk-Based Quality Management (RBQM) expertise and technology in the Chinese region. This partnership will increase clinical trial efficiency and reduce deviation and bias to obtain accurate patient outcomes.
CluePoints' cloud-based products are deployed to support traditional on-site monitoring, medical review, and quality to drive an RBQM approach to study execution and ultimately achieve ICH E6 (R2) compliance.
The US Food and Drug Administration is also currently working with CluePoints as part of a cooperative research and development agreement (CRADA) to utilize CSM technology to inform the site inspection process and develop advanced statistical tests to identify moderators of treatment effect and analyze real-world evidence.