Article(id=1291404624620150863, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404554201985968, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.06.024, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1729699200000, receivedDateStr=2024-10-24, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824455646, onlineDateStr=2026-08-04, pubDate=1743091200000, pubDateStr=2025-03-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824455646, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824455646, creator=13701087609, updateTime=1785824455646, updator=13701087609, issue=Issue{id=1291404554201985968, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='6', pageStart='751', pageEnd='900', issueExtLink='null', onlineDate='null', pubDate='1743091200000', pubDateStr='2025-03-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824438858, creator='13701087609', updateTime=1785824438858, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=877, endPage=880, ext={EN=ArticleExt(id=1291404625035386960, articleId=1291404624620150863, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Design and practice of digital intelligence quality management system in drug clinical trials, columnId=1246531412438966969, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Reader’s Field, runingTitle=null, highlight=null, articleAbstract=
Objective

To explore the design and application of digital intelligence quality control technology in drug clinical trials, aiming to improve the quality and efficiency of these trials.

Methods

Based on the characteristics and requirements of quality control in drug clinical trials, a digital intelligence quality control model was designed and applied throughout the entire process of drug clinical trials. The system’s performance and security were evaluated.

Results

The digital intelligence quality management system can significantly enhance the accuracy and completeness of clinical trial data, improve the efficiency of drug clinical trials, and strengthen real-time monitoring capabilities to ensure compliance and safety of the trials.

Conclusion

The digital intelligence quality management system can optimize resource allocation, shorten trial duration, and reduce overall costs. It provides new perspectives and methodologies for quality control in drug clinical trials, laying a reliable foundation for the digital transformation of the biopharmaceutical industry.

, authors=Hui-qin LU1a, Zu-mei LIU1a, Yan CHEN1a, Wan-min LIAN1b, Qiu-tian YU1a, authorsList=Hui-qin LU, Zu-mei LIU, Yan CHEN, Wan-min LIAN, Qiu-tian YU, authorCompany=null, correspAuthors=Hui-qin LU, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1291404625878442065, articleId=1291404624620150863, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=药物临床试验中数智化质量管理系统的设计与实践, columnId=1246531414020219657, journalTitle=中国临床药理学杂志, columnName=读者园地, runingTitle=null, highlight=null, articleAbstract=
目的

探讨数智化质量控制技术在药物临床试验中的设计应用,旨在提高药物临床试验的质量和效率。

方法

结合药物临床试验质控特点和相关需求,在药物临床试验全流程中设计并应用数智化质控模式,对系统性能及安全性作出评价。

讨论

数智化质量管理系统可显著提高临床试验的数据准确性和完整性,提升药物临床试验效率,增强对临床试验的实时监控能力,确保试验的合规性和安全性。

结论

数智化质量管理系统可优化资源分配,缩短试验周期,降低整体成本,为药物临床试验的质控提供了新的视角和方法论,对推动生物医药产业的数智化转型奠定了可靠基础。

, authors=卢慧勤1a, 刘祖玫1a, 陈燕1a, 连万民1b, 余秋钿1a, authorsList=卢慧勤, 刘祖玫, 陈燕, 连万民, 余秋钿, authorCompany=null, correspAuthors=卢慧勤, authorNote=

卢慧勤(1969-),男,主任药师,硕士生导师,主要从事药物临床试验及临床研究管理工作

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卢慧勤 Tel: (020)89169188 E-mail:
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卢慧勤(1969-),男,主任药师,硕士生导师,主要从事药物临床试验及临床研究管理工作

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药物临床试验中数智化质量管理系统的设计与实践
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卢慧勤 1a , 刘祖玫 1a , 陈燕 1a , 连万民 1b , 余秋钿 1a
中国临床药理学杂志 | 读者园地 2025,41(6): 877-880
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中国临床药理学杂志 |读者园地 2025 , 41 (6) : 877 -880
药物临床试验中数智化质量管理系统的设计与实践
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卢慧勤1a , 刘祖玫1a, 陈燕1a, 连万民1b, 余秋钿1a
作者信息
  • 1a.广东省第二人民医院,临床研究部,广东 广州 510317
  • 1b.广东省第二人民医院,信息科,广东 广州 510317
通讯作者:
卢慧勤 Tel: (020)89169188 E-mail:
作者简介:

卢慧勤(1969-),男,主任药师,硕士生导师,主要从事药物临床试验及临床研究管理工作

Design and practice of digital intelligence quality management system in drug clinical trials
Hui-qin LU1a , Zu-mei LIU1a, Yan CHEN1a, Wan-min LIAN1b, Qiu-tian YU1a
Affiliations
  • 1a.Clinical Research Department, Guangdong Second Provincial General Hospital, Guangzhou 510317, Guangdong Province, China
  • 1b.Information Technology Department, Guangdong Second Provincial General Hospital, Guangzhou 510317, Guangdong Province, China
出版时间: 2025-03-28 doi: 10.13699/j.cnki.1001-6821.2025.06.024
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目的

探讨数智化质量控制技术在药物临床试验中的设计应用,旨在提高药物临床试验的质量和效率。

方法

结合药物临床试验质控特点和相关需求,在药物临床试验全流程中设计并应用数智化质控模式,对系统性能及安全性作出评价。

讨论

数智化质量管理系统可显著提高临床试验的数据准确性和完整性,提升药物临床试验效率,增强对临床试验的实时监控能力,确保试验的合规性和安全性。

结论

数智化质量管理系统可优化资源分配,缩短试验周期,降低整体成本,为药物临床试验的质控提供了新的视角和方法论,对推动生物医药产业的数智化转型奠定了可靠基础。

数智化质控  /  临床试验  /  人工智能  /  大数据分析  /  云计算
Objective

To explore the design and application of digital intelligence quality control technology in drug clinical trials, aiming to improve the quality and efficiency of these trials.

Methods

Based on the characteristics and requirements of quality control in drug clinical trials, a digital intelligence quality control model was designed and applied throughout the entire process of drug clinical trials. The system’s performance and security were evaluated.

Results

The digital intelligence quality management system can significantly enhance the accuracy and completeness of clinical trial data, improve the efficiency of drug clinical trials, and strengthen real-time monitoring capabilities to ensure compliance and safety of the trials.

Conclusion

The digital intelligence quality management system can optimize resource allocation, shorten trial duration, and reduce overall costs. It provides new perspectives and methodologies for quality control in drug clinical trials, laying a reliable foundation for the digital transformation of the biopharmaceutical industry.

digital intelligent quality control  /  clinical trial  /  artificial intelligence  /  big data analytics  /  cloud computing
卢慧勤, 刘祖玫, 陈燕, 连万民, 余秋钿. 药物临床试验中数智化质量管理系统的设计与实践. 中国临床药理学杂志, 2025 , 41 (6) : 877 -880 . DOI: 10.13699/j.cnki.1001-6821.2025.06.024
Hui-qin LU, Zu-mei LIU, Yan CHEN, Wan-min LIAN, Qiu-tian YU. Design and practice of digital intelligence quality management system in drug clinical trials[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (6) : 877 -880 . DOI: 10.13699/j.cnki.1001-6821.2025.06.024
  • 国家卫生健康委医院管理研究所医院药学高质量发展研究基金资助项目(NIHAYS2312)
  • 广东省医学科学技术研究基金资助项目(A2022095)
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2025年第41卷第6期
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doi: 10.13699/j.cnki.1001-6821.2025.06.024
  • 接收时间:2024-10-24
  • 首发时间:2026-08-04
  • 出版时间:2025-03-28
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  • 收稿日期:2024-10-24
基金
国家卫生健康委医院管理研究所医院药学高质量发展研究基金资助项目(NIHAYS2312)
广东省医学科学技术研究基金资助项目(A2022095)
作者信息
    1a.广东省第二人民医院,临床研究部,广东 广州 510317
    1b.广东省第二人民医院,信息科,广东 广州 510317

通讯作者:

卢慧勤 Tel: (020)89169188 E-mail:
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2种不同金属材料的力学参数

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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
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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