在大数据时代背景下,新兴技术的发展和应用使得临床研究呈现出信息化、自动化、数字化和智能化的发展趋势,对临床数据管理工作流程和效率产生了影响的同时,也对临床数据管理人员需要掌握的专业知识和能力架构提出了新的要求。在临床数据管理向临床数据科学发展变迁的进程中,临床数据管理人员可把握这一重要时机,定义未来,重塑自身。
In big data era, the development and application of emerging technologies advance informatization, automization, digitization and Intelligentization in clinical research, which not only has a great impact on the work process and efficiency of clinical data management, but also requests CDM professionals to master new knowledge and skillset. As the clinical data management is now evolving to clinical data science, CDM professionals need to take this opportunity to define and reshape their future role.
第四届临床数据管理年度大会将于2021年6月17-19日在中国上海举办,本届大会主题为“数字化转型推动临床数据管理”。届时受邀的国际国内行业专家们将围绕基于风险的数据审核、智能化数字技术在数据管理工作中的探索、数字化智能化时代数据管理员的定位及成长路径,新法规下的临床试验数据递交、新药国际递交的法规要求和核查要点等多个热点议题,探讨技术变革和法规要求变化等层面带来的挑战、机遇和应对策略。
Clinical Data Management 2021 China Conference will be held in Shanghai, China from June 17 to 19, 2021, themed “Drive CDM with Digital Transformation” . The invited international and domestic experts will discuss about challenges, opportunities and corresponding tactics brought by the changes of new regulations and technology innovation. Hot topics cover risk-based data review, the exploration of intelligent digital technology in data management, the positioning and growth path of data manager in digital times, clinical trial data submission under new regulation, regulation and inspection focus of Chinese new drugs going international, etc.
本届大会还将在6月17日开展会前培训和研讨,包含DM项目管理、电子临床数据(从采集到注册提交)以及高效数据核查三个专题,由具有实操经验的临床数据管理资深专家现场授课,助力数据管理人员提档转型。
Two parallel tracks of pre-conference workshops will be arranged on June 17. Topics include DM project management, electronic clinical data (from collection to registration and submission) and efficient data review. Instructors with hands-on experience will give lectures and facilitate the study and help CDM professionals skill up.