HiRO and CluePoints Partnership Offers RBQM Opportunities in China
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.
HiRO and CluePoints Partnership Offers RBQM Opportunities in China
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
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