中国临床药理学杂志2025，Vol.41Issue(6)：877-880,4.DOI:10.13699/j.cnki.1001-6821.2025.06.024
药物临床试验中数智化质量管理系统的设计与实践
Design and practice of digital intelligence quality management system in drug clinical trials
摘要
Abstract
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.关键词
数智化质控/临床试验/人工智能/大数据分析/云计算Key words
digital intelligent quality control/clinical trial/artificial intelligence/big data analytics/cloud computing分类
医药卫生引用本文复制引用
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[J].中国临床药理学杂志,2025,41(6):877-880,4.基金项目
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) （NIHAYS2312）
广东省医学科学技术研究基金资助项目(A2022095) （A2022095）
