Harvest Integrated Research Organization (HiRO), a clinical research organization (CRO) headquartered in Shanghai, China, signed a cooperation agreement with CluePoints to be the exclusive supplier designated by CluePoints to provide HiRO customers in Greater China State-of-the-art Risk-Based Quality Management (RBQM) expertise and technical services. This market-leading collaboration will improve clinical trial efficiency, reduce bias and deviation rates and achieve accurate subject outcomes.

CluePoints, a leading provider of risk-based quality management (RBQM) and clinical trial data oversight software based in Pennsylvania, USA, offers a more ideal approach to identifying, visualizing, managing and documenting potentially compromised subjects safety and the trial risk of delaying the approval of the investigational drug. CluePoints' cloud offering is based on Central Statistical Monitoring (CSM) technology to support traditional on-site monitoring, medical review and quality to drive risk-based quality management (RBQM) study execution methods for perfect compliance with clinical trial quality management Standardize clinical trials for ICH E6(R2).

The U.S. Food and Drug Administration (FDA) is also currently working with CluePoints as part of a Collaborative Research and Development Agreement (CRADA) to utilize CSM technology to inform the field audit process and to develop advanced statistical tests to determine the modulation of treatment effects factors and analyze real-world evidence.

Allen Lin, Head of Quality Management at HiRO, said: "HiRO is committed to bringing international standards and leading clinical trial expertise and services to the Asia-Pacific region. Combining CluePoints' professional RBQM system with HiRO's own extensive clinical trial service experience , which means that we will be able to expand into specific markets. The cooperation with CluePoints can not only introduce highly specialized RBQM data analysis concepts into the Asia-Pacific market, but also promote the development and improvement of the entire industry in the region, and respond to The future trend of clinical trial data management."

CROs must adapt quickly to the Covid-19 and post-pandemic periods. Therefore, the focus should be on the most important critical processes and key data, including incremental versions of Key Risk Indicators (KRIs) and Quality Tolerances (QTLs). However, most risk-based approaches in China are currently in the planning and launch stages, and a significant obstacle to progress is the lack of effective systematic tools. HiRO's strategic partnership with CluePoints aims to address and overcome this issue, helping HiRO's clients improve efficiency and subject safety by improving data quality.

CluePoints technology and services enable sponsors and CROs to rapidly implement specific risk management solutions, providing assurance to the industry that critical risks can be identified, mitigated and centrally addressed and monitored.

Patrick Hughes, Co-Founder and Chief Commercial Officer of CluePoints, said: "We are delighted to partner with HiRO to help increase the usage of RBQM systems in Greater China and provide CROs with a best-in-class solution. Our RBQM expertise, coupled with HiRO Experience and understanding of the region's unique challenges will improve clinical trial efficiency and subject outcome accuracy, thereby enhancing subject safety and speeding time to market."