King of Prussia, PA, December 13, 2021: Harvest Integrated Research Organization (HiRO), a Shanghai-based Clinical Research Organization (CRO), has collaborated with CluePoints, the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight Software, to provide Risk-Based Quality Management (RBQM) expertise and technology in the Chinese region. This market-leading partnership will increase clinical trial efficiency and reduce deviation and bias to obtain accurate patient outcomes.
CluePoints offers an ideal way to identify, visualize, manage, and document trial risks that could compromise patient safety and delay the approval of investigational products. Underpinned by Central Statistical Monitoring (CSM) technology, 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 (FDA) 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 is committed to bringing clinical trial expertise and services that both meet international standards and are at the forefront of advancements to the Asia Pacific region,” says Allen Lin, Head of Quality Management at HiRO. “Combining the professional RBQM system at CluePoints and HiRO’s own extensive clinical trial service experience means we can expand specific markets. This partnership will not only bring the concept of highly specialized RBQM data analysis to the Asia-Pacific market, but it will also act as a catalyst for the region’s industry as a whole to upgrade and respond to the digital clinical trial movement.”
CROs must adapt quickly, both during COVID-19 and in a post-pandemic era. Therefore, it is crucial to focus on what matters most – the critical processes and critical data, including incremental versions of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs). However, most risk-based approaches in China are currently in the planning and start-up stages. A significant barrier to progress is the lack of an effective enabling system. HiRO’s partnership with CluePoints aims to address and overcome this, helping HiRO’s customers improve efficiency and patient safety by increasing data quality.
CluePoints technologies and services allow sponsors and CROs to quickly implement specific risk management solutions, offering the industry assurance that key risks are identified, mitigated, centrally addressed, and monitored with confidence.
“We are delighted to be working with HiRO to help increase adoption of RBQM approaches in the Chinese market and offer this best-in-class solution for CROs,” says Patrick Hughes, Co-Founder and Chief Commercial Officer at CluePoints. “Our RBQM expertise, combined with HiRO’s experience and knowledge of the particular challenges in the region, will increase clinical trial efficiency and patient outcome accuracy resulting in improved patient safety and faster market approval.”
HiRO is a China-based, globally oriented innovative clinical research organization (CRO) headquartered in Shanghai, China. With global operations and integration capabilities, the company is dedicated to providing its clients with a full range of solutions and services. HiRO strives to become a market-leading, integrated global clinical research organization that works hand-in-hand with biotech companies and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide.
CluePoints is the premier provider of Risk-Based Study Execution (RBx) and Data Quality Oversight software. CluePoints products utilize comprehensive statistical algorithms to determine clinical trial data quality, accuracy, and integrity, both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6(R2), CluePoints is deployed to support central and on-site monitoring, medical review, quality risk management, and to drive a holistic risk-based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls, and solution implementation, these elements allow for success to adhere to global regulatory guidance. The result is increased operational efficiency, lower costs, and reduced regulatory submission risk as part of the industry paradigm shift to RBx.