Professional profile
About Ying
Ying Chen advises sponsors, CROs, biotech companies and research institutions on clinical trial contracting, human genetic resources compliance and health data protection from Hangzhou.
Ms. Chen practices at a Hangzhou law firm. She was admitted in 2015 and has about eleven years of professional experience, working in English and Mandarin with Zhejiang Bar Association credentials on file.
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Clinical trials are calendar sports. Enrollment lag fights are won or lost in milestone definitions signed years earlier. She drafts liquidated damages that tie holdbacks to measurable KPIs with cure periods, and carves out sponsor-caused delay such as protocol freezes, drug supply and HGR gates.
If a global protocol assumes free secondary genomics and offshore bioinformatics, China will not adapt later. She gates HGR before first-patient-in.
She draws the data flow diagram: collection site, storage, processing including cloud, who can access, and what leaves mainland China. The Chinese responsible entity and every CRO and lab are named. Silent outbound mirrors are frozen in vendor SOPs.
Residual samples collected for one trial become a regulatory project the moment someone proposes another trial, biomarker fishing or offshore sequencing. She runs the consent scope, ethics approval, materials outbound and HGR practice analysis before the first aliquot ships.
She advises on anonymisation versus de-identification, re-identification risk and documentation for audits under Chinese privacy practice.
Identifiers removed is not the end of the analysis if quasi-identifiers re-identify patients in small cohorts. Keyed coding held by the sponsor may still be personal information processing. Vendor claims of anonymous analytics need technical evidence, not a DPA clause alone.
Purpose binding, legal basis and consent map, minimisation, transfer path and vendor DPIA are sequenced before model training on a laptop export.
Provide protocol versions, amendment log, site list, screening and enrollment funnel exports, and any HGR or data compliance questions already raised. Scope is confirmed in writing through this profile's inquiry channel.
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