PHILADELPHIA, Sept. 26, 2023 /PRNewswire/ -- Signant Health, the leader in evidence generation for modern clinical trials, announced today it has finalized technical and operational investments required to support customers' compliance with China's Personal Information Protection Law (PIPL) for clinical trial data collection.

费城，2023年9月26日/PRNewswire/-现代临床试验证据生成领导者Signant Health今天宣布，它已经完成了支持客户遵守中国个人信息保护法（PIPL）所需的技术和运营投资。临床试验数据收集。

The PIPL includes provisions that govern how clinical research sponsors process and transfer data collected from Chinese patients. .

PIPL包括管理临床研究发起人如何处理和传输从中国患者收集的数据的规定。 .

Although Signant is considered an entrusted partner under the terms of PIPL and does not have any direct obligations or responsibilities under the law, the company invested significant resources to support clinical research sponsors conducting trials in China, ensuring its flagship electronic clinical outcome assessment (eCOA) solution fully complies with the law's provisions related to the handling of clinical trial data collected from Chinese patients.

尽管Signant根据PIPL条款被视为委托合作伙伴，并且根据法律没有任何直接义务或责任，但公司投入了大量资源支持在中国进行试验的临床研究赞助商，确保其旗舰电子临床结果评估（eCOA）解决方案完全符合法律有关处理从中国患者收集的临床试验数据的规定。

Signant's infrastructure investment comprehensively addresses both cases where a sponsor requires Chinese security assessment approval, and where a sponsor can operate without it.   .

Signant的基础设施投资全面解决了赞助商需要中国安全评估批准的情况，以及赞助商可以在没有它的情况下运营的情况。

'In recognition of the People's Republic of China taking a tougher stance on protecting its citizens' data privacy rights through the Personal Information Protection Law (PIPL), Signant has made substantial, voluntary investments to ensure clinical trial data collected from Chinese patients by our core eCOA solution fully complies with PIPL,' said Sanjiv Waghmare, chief product officer at Signant Health.

“鉴于中华人民共和国通过个人信息保护法（PIPL）在保护公民数据隐私权方面采取了更为严峻的立场，Signant进行了大量自愿投资，以确保我们的核心eCOA从中国患者收集临床试验数据解决方案完全符合PIPL，“Sanjiv Waghmare说，Signant Health的首席产品官。

'We are committed to ensuring we protect the integrity and usability of Chinese patient data for our customers' trials and regulatory submissions. To our best knowledge, Signant is the only eClinical provider that has made these specific investments in addressing PIPL, which include developing and implementing a solution to satisfy the requirement of storing data domestically first prior to transferring it outside of China.'.

“我们致力于确保我们为客户的试验和监管提交保护中国患者数据的完整性和可用性。据我们所知，Signant是唯一一家在解决PIPL问题上做出这些具体投资的临床供应商，其中包括开发和实施解决方案，以满足在将数据转移到中国境外之前首先在国内存储数据的要求。

According to the intelligence platform GlobalData, 43% of industry-sponsored clinical trial starts registered in the first half of 2023 include at least one research site in China, an increase from 38% in calendar-year 2022. Signant stands ready to collect, store, and manage customers' clinical trial data in compliance with China's PIPL.

根据智能平台GlobalData的数据，在2023年上半年开始注册的行业赞助临床试验中，有43%在中国至少包括一个研究点，比2022日历年的38%有所增加。Signant随时准备根据中国的PIPL收集，存储和管理客户的临床试验数据。

Signant's compliant eCOA solution is an important resource for clinical development organizations interested in collecting clinical outcome assessments in China.   .

Signant的合规eCOA解决方案是有兴趣在中国收集临床结果评估的临床开发组织的重要资源。   .

About Signant Health

关于Signant Health

Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 25 years, over 600 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, EDC, eConsent, RTSM, supply chain management, and data quality analytics.

Signant Health是证据生成公司。我们专注于利用软件，深度治疗和科学知识以及运营专业知识，持续捕捉，汇总和揭示传统，虚拟和混合试验模型临床研究的质量证据。25年来，超过600家赞助商和各种规模的CRO（包括所有前20名制药公司）都为远程和基于站点的eCOA，EDC，eConsent，RTSM，供应链管理和数据质量分析提供了可信的Signant解决方案。

Learn more at www.signanthealth.com..

在www.signanthealth.com了解更多信息。。

Contact: Heather BilinskiHeather.Bilinski@signanthealth.comM: +1 610 400 4141

联系人：HeatherBilinskiHeather.Bilinski@signanthealth.comM：+1 610 400 4141

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SOURCE Signant Health

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