HiRO与CluePoints 达成战略合作,提供中国市场最先进的RBQM专业技术和服务

上海贺维斯特医药科技有限公司Harvest Integrated Research Organization(HiRO)，总部位于中国上海的临床研究组织（CRO），与CluePoints签署合作协议,为 CluePoints 指定的独家供应商，在大中华地区提供HiRO客户最先进的基于风险的质量管理（RBQM）专业知识和技术服务。此次市场领先的合作将提高临床试验效率，减少偏差和偏离率并获得准确的受试者结果。

CluePoints是一家基于风险的质量管理(RBQM)和临床试验数据监督软件的主要供应商，位于美国宾夕法尼亚州，该公司提供一种更理想的方法，用于识别、可视化、管理和记录可能危及受试者安全和延迟试验药物批准的试验风险。CluePoints的云产品以中央统计监测（CSM）技术为基础，用于支持传统的现场监查、医疗审查和质量，以推动基于风险的质量管理(RBQM)研究执行方法，实现完美符合临床试验质量管理规范ICH E6(R2)的临床试验。

作为合作研发协议（CRADA）的一部分，美国食品和药物管理局（FDA）目前也正与CluePoints合作，利用CSM技术通知现场稽查流程，并开发先进的统计测试方法，以确定治疗效果的调节因素并分析真实世界证据。

HiRO质量管理主管Allen Lin 表示: ”HiRO致力于为亚太地区带来符合国际标准和处于领先地位的临床试验专业技术与服务。将CluePoints专业的RBQM系统加上HiRO本身丰富的临床试验服务经验相结合，意味着我们将可拓展特定的市场。与CluePoints的合作不仅仅可以将高度专业化的RBQM数据分析概念引入亚太市场，另一方面也可以促进该地区整个行业的发展和产业的提升，并因应临床试验数据化管理的未来趋势。”

CRO必须迅速适应Covid-19期和后流行期。因此，重点应该放在最重要的关键流程和关键数据上，包括增量版的关键风险指标（KRI）和质量容忍度（QTL）。然而，中国大多数基于风险的方法目前都处于规划和启动阶段，取得进展的一个重大障碍是缺乏有效的系统工具。HiRO与CluePoints的战略合作旨在解决和克服此问题，帮助HiRO的客户通过提高数据质量来提升效率和受试者的安全性。

CluePoints的技术和服务让申办方和CRO能够快速实施特定的风险管理解决方案，为行业提供保证，确保能够识别、缓解并集中处理和监控关键风险。

CluePoints联合创始人兼首席商务官Patrick Hughes表示:“我们很高兴与HiRO合作，帮助提高RBQM系统在大中华地区的使用率，并为CRO提供一流的解决方案。我们的RBQM专业技术，加上HiRO对该地区特殊挑战的经验和了解，将提高临床试验效率和受试者结果准确性，从而强化受试者安全性和加快上市速度。”

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.”