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Architecture design and application exploration of an intelligent quality control system for new traditional chinese medicine drug clinical trials from an institutional perspective
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Wan-zhong SHI1, Yi-hui HU1, Yi-chen ZHOU1, Xi-yi ZHANG1, Cheng-bin XU1, Ping XU1, Liu YANG2, Lei-lei ZHU1, *, Wei-an YUAN1, *
Chinese Journal of New Drugs | 2026, 35(19) : 2082 - 2089
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Chinese Journal of New Drugs | 2026, 35(19): 2082-2089
Architecture design and application exploration of an intelligent quality control system for new traditional chinese medicine drug clinical trials from an institutional perspective
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Wan-zhong SHI1, Yi-hui HU1, Yi-chen ZHOU1, Xi-yi ZHANG1, Cheng-bin XU1, Ping XU1, Liu YANG2, Lei-lei ZHU1, *, Wei-an YUAN1, *
Affiliations
  • 1 Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
  • 2 Medcare Health Technology (Shanghai) Co., Ltd., Shanghai 200062, China
Published: 2026-10-15 doi: 10.20251/j.cnki.1003-3734.2026.19.009
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AbstractIn response to the limitations of the traditional quality control (QC) model for clinical trials of new traditional Chinese medicine (TCM) drugs, this paper explores the construction of a full-process intelligent QC system centered on artificial intelligence (AI) technology. From the perspective of clinical trial institutions, by integrating currently relatively mature AI technologies, this paper proactively plans QC application scenarios for clinical trials of new TCM drugs and proposes an intelligent QC system architecture covering the entire process before, during, and after the trial. It focuses on elaborating the framework, module composition, main functions, key technical features, and implementation pathways of the intelligent QC system, including data security, management of drugs and biospecimens, protocol evaluation and start-up preparation, intelligent screening and recruitment, risk monitoring and early warning, data governance and quality assessment, and knowledge accumulation and mining. The clinical trial QC system deeply integrated with AI technology can enable institutions to achieve a paradigm shift in QC, shifting from passive response to active prevention and from post-hoc verification to real-time monitoring, thereby improving the quality and efficiency of clinical trials.

new traditional chinese medicine drugs  /  clinical trials  /  quality control  /  artificial intelligence  /  whole-process management
史万忠, 胡薏慧, 周一辰, 张习艺, 徐铖斌, 徐平, 羊柳, 朱蕾蕾, 元唯安. 基于机构视角的中药新药临床试验智能质控系统架构设计与应用探索. 中国新药杂志, 2026 , 35 (19) : 2082 -2089 . DOI: 10.20251/j.cnki.1003-3734.2026.19.009
Wan-zhong SHI, Yi-hui HU, Yi-chen ZHOU, Xi-yi ZHANG, Cheng-bin XU, Ping XU, Liu YANG, Lei-lei ZHU, Wei-an YUAN. Architecture design and application exploration of an intelligent quality control system for new traditional chinese medicine drug clinical trials from an institutional perspective[J]. Chinese Journal of New Drugs, 2026 , 35 (19) : 2082 -2089 . DOI: 10.20251/j.cnki.1003-3734.2026.19.009
Appendix
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Year 2026 volume 35 Issue 19
71
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Article Info
doi: 10.20251/j.cnki.1003-3734.2026.19.009
  • Receive Date：2026-04-28
  • Online Date：2026-10-29
  • Published：2026-10-15
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  • Received：2026-04-28
Funding
Affiliations
    1 Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
    2 Medcare Health Technology (Shanghai) Co., Ltd., Shanghai 200062, China
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小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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