Ghrieb Zineb, Walter-Petrich Anouk, Huang Jin, Chevret Sylvie, Montlahuc Claire, Resche-Rigon Matthieu, Kiladjian Jean-Jacques, Allaoua Souhil, Abdeljalil Nabil
Centre d'investigation cliniques (Inserm CIC-1427), université de Paris Cité, AP-HP, hôpital Saint-Louis, 75010 Paris, France.
Service de biostatistique et d'information médicale (SBIM), université de Paris cité, AP-HP, hôpital Saint-Louis, 75010 Paris, France.
Therapie. 2024 Sep-Oct;79(5):519-531. doi: 10.1016/j.therap.2023.12.004. Epub 2024 Jan 17.
The main objectives of multidisciplinary clinical investigation center (CIC-P) are to facilitate the availability of new drugs for patients, to enhance the visibility and attractiveness of French clinical research, to improve the quality of early phase trials, and to enhance the value of academic research by evaluating molecules in rare diseases. Since 2017, the CIC-P has been committed to a quality approach process, launching in 2018 its first satisfaction survey on patient care and clinical trial management of all its employees. A second satisfaction survey targeted by profession type was to be launched in 2020, in view of the requirements of the ISO 9001:2015 standard, but the process was interrupted following the coronavirus diseases 2019 (COVID-19) pandemic. The successful reorganization of the CIC-P activity during the first containment of the COVID-19 pandemic was driven by the implementation of a quality management system that promotes continuous improvement through the organization and involvement of all the staff. This voluntary and participative approach motivated the CIC-P to apply for the organizational sesame. The ISO 9001:2015 certification of CIC-P aims at increasing its performance, to satisfying its customers and to fully integrate its activities in a continuous improvement process, according to the requirements of this international standard, through the deployment of quality tools such as The Deming wheel (PDCA), an indispensable tool for transformation and reorganization; the analysis of the environment by the strengths, weakness, opportunities, threats (SWOT) analysis tool; the analysis and management of risks by the FMEA method, and all with performance indicators (SMART) and precise objectives at each stage of a project/process. The implementation of satisfaction questionnaires remains the essential tool for evaluating the expectations and needs of interested parties, but also for improving the quality of CIC-P activities and services. All these tools put in place have allowed us to continuously improve the means of production and to constantly improve our organization.
多学科临床研究中心（CIC-P）的主要目标是为患者提供新药，提高法国临床研究的知名度和吸引力，改善早期试验的质量，并通过评估罕见病分子来提升学术研究的价值。自2017年以来，CIC-P一直致力于质量提升工作，于2018年开展了首次针对其所有员工的患者护理和临床试验管理满意度调查。鉴于ISO 9001:2015标准的要求，原计划于2020年开展第二次按职业类型进行的满意度调查，但该进程在2019冠状病毒病（COVID-19）大流行后中断。在COVID-19大流行首次封锁期间，CIC-P活动的成功重组得益于质量管理体系的实施，该体系通过全体员工的组织和参与来促进持续改进。这种自愿和参与式的方法促使CIC-P申请组织认证。CIC-P的ISO 9001:2015认证旨在提高其绩效，满足客户需求，并根据这一国际标准的要求，通过部署诸如戴明轮（PDCA）等质量工具，将其活动全面融入持续改进过程，戴明轮是转型和重组不可或缺的工具；运用优势、劣势、机会、威胁（SWOT）分析工具进行环境分析；通过失效模式与效应分析（FMEA）方法进行风险分析和管理，并且在项目/流程的每个阶段都设有绩效指标（SMART）和精确目标。实施满意度调查问卷仍然是评估相关方期望和需求的重要工具，同时也是提高CIC-P活动和服务质量的重要手段。所有这些已实施的工具使我们能够不断改进生产方式，持续完善我们的组织。
