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论文编号：	14221
作者编号：	2320213749
上传时间：	2023/12/8 20:18:24
中文题目：	A公司临床试验质量管理优化研究
英文题目：	Research on Optimization of Clinical Trial Quality Management in Company A
指导老师：	张晓飞
中文关键字：	临床试验；合同研究组织；质量管理
英文关键字：	Clinical Trials; Contract Research Organization; Quality Management
中文摘要：	2022年1月，国家发展改革委、工信部等九部门联合印发了《“十四五”医药工业发展规划》，其中特别指出必须加快产品创新及产业化技术突破。在“十四五规划”改革的带动下，国内医药领域迅速发展，催生出CRO这一新兴行业的迅速兴起。2023年，医药领域掀起的反腐风暴受到社会各界广泛关注，导致医药市场的整体低迷，CRO公司作为其中的一环也受到影响。再加上国家食品药品监督管理总局对临床试验质量高度重视和从严治理的坚定决心，CRO公司需采用质量管理手段以保证持续发展，在残酷的市场竞争中取得优势。质量管理是保障企业战略及愿景落实的重要方法，同时也是企业内部控制的主要路径，可以提高质量管理水平，合理地对公司进行开源节流以获取最大收益，同时又能够提升企业在市场中的竞争力，提高企业的品牌价值。 基于此现状，本文通过对国内外相关的质量管理研究的文献进行了研究和整理，详细阐述了临床试验质量管理相关的理论知识和药物临床试验质量管理规范（GCP）法规，以A公司主营业务临床试验质量管理现状为基础，分析其临床试验质量管理的现状，通过访谈公司相关人员发现的问题进行研究分析，进而得到解决问题的方法和保障措施。首先，本文对A医药公司现状进行概述，并对公司的项目流程进行了具体的描述，如组织架构、项目流程等。其次，对A医药公司企业临床试验质量体系方面存在的问题进行了系统的分析。最后，通过之前的研究和分析，对A公司临床试验质量管理体系给出优化方案。以CRO公司的视角从公司组织架构、临床试验质量预防控制、临床试验质量文件管理、临床试验质量风险识别评估和临床试验质量管理人员培训五个方面对A公司临床试验质量工作的优化提出可行性建议。 通过本研究，不仅发现了A公司临床试验质量管理中存在的问题，也提出了针对性的优化策略。CRO公司作为临床试验的参与者，需要承担起临床试验质量重要责任人的身份。建立符合要求的质量管理体系，保证临床试验的质量。本研究希望这些发现和建议能对A公司及其他相关公司在临床试验质量管理方面提供有益的参考。
英文摘要：	In January 2022, nine government departments, including the National Development and Reform Commission and the Ministry of Industry and Information Technology, jointly issued the "14th Five-Year Plan for the Development of the Pharmaceutical Industry", which emphasized the need to accelerate product innovation and technological breakthroughs for industrialization. Fueled by the reforms outlined in the "14th Five-Year Plan", the domestic pharmaceutical sector has experienced rapid growth, giving rise to the rapid emergence of the Contract Research Organization (CRO) industry. In 2023, the anti-corruption campaign that swept through the pharmaceutical sector garnered widespread attention, leading to a downturn in the pharmaceutical market, which also impacted CRO companies. Furthermore, the State Food and Drug Administration's heightened focus on clinical trial quality and its determination to enforce strict regulations added to the challenges faced by CRO companies. To ensure sustainable development and gain a competitive edge in the fiercely competitive market, CRO companies must employ quality management techniques. Quality management is a vital method to ensure the implementation of an enterprise's strategies and visions, as well as the primary path for internal control within the organization. It enhances the quality of management processes, allows for cost-effective resource allocation, and improves a company's competitive position and brand value in the market. In light of this context, this thesis conducts a detailed review of relevant quality management research both domestically and internationally. It comprehensively elucidates theoretical knowledge related to clinical trial quality management and the regulatory guidelines for Good Clinical Practice (GCP) in drug clinical trials. Building on the current state of clinical trial quality management in Company A's core business, the thesis analyzes the existing conditions of its clinical trial quality management, investigates the issues identified during interviews with relevant company personnel, and then offers solutions and safeguards. To begin, an overview of Company A's pharmaceutical business is provided, including specific descriptions of the project processes such as organizational structure and project workflow. Subsequently, a systematic analysis of the issues within Company A's clinical trial quality system is presented. Finally, based on the research and analysis conducted earlier, the thesis offers optimization strategies for Company A's clinical trial quality management system. From the perspective of a CRO company, feasible recommendations for optimizing Company A's clinical trial quality work are presented, covering aspects such as organizational structure, prevention and control of clinical trial quality, management of clinical trial quality documents, identification and assessment of clinical trial quality risks, and training of clinical trial quality management personnel. Through the research, not only are the problems in Company A's clinical trial quality management identified, but targeted optimization strategies are also proposed. As active participants in clinical trials, CRO companies play a crucial role in ensuring the quality of clinical trials. Establishing a compliant quality management system is essential to guarantee the quality of clinical trials. This study aims to provide valuable insights and recommendations for Company A and other related companies in the field of clinical trial quality management.
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