PHILADELPHIA, PA – September 26, 2023 – 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. The PIPL includes provisions that govern how clinical research sponsors process and transfer data collected from Chinese patients.
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. Signant’s infrastructure investment comprehensively addresses both cases where a sponsor requires Chinese security assessment approval, and where a sponsor can operate without it.
“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. “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.”
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. Signant’s compliant eCOA solution is an important resource for clinical development organizations interested in collecting clinical outcome assessments in China.
About 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. Learn more at www.signanthealth.com.