China CDISC Day | 29 August 2025 Program
9:00 - 10:40
Session 1: Opening Plenary and Keynote Presentations
John Wang, Caidya
9:00 - 9:10
Welcome Address: CDISC Strategy and the Future
Chris Decker, CDISC President and CEO
9:10 - 9:55
AI-Driven Transformation of Clinical Trials AI 助力临床试验变革
Yan Xiaoyan, Director, Department of Biostatistics, Peking University Clinical Research Institute 阎小妍, 生物统计部主任, 北京大学临床研究所
9:55 - 10:10
360i Update: Enabling Standards Driven Automation from Study Design Through Results
Chris Decker, CDISC President and CEO
10:10 - 10:40
Technology Enabled Standards: Leveraging Technology, Open-Source Solutions, and AI to Drive Standards Automation
Julie Smiley, CDISC VP, Data Sciences
10:40 - 11:10
Morning Break
11:10 - 12:00
Session 2: Second Plenary
11:10 - 11:40
Secondary Keynote Presentation
Haibo Wang, Senior Director, Project Management Dept. , Beijing ClinFunction Co., Ltd.
11:40 - 12:00
CDISC China Update
John Wang, Caidya, C3C Chair and Victor Wu, Data Science Express, C3C Past-Chair
12:10 - 13:40
Lunch Break
13:40 - 14:40
Session 3: CDISC Standards Implementation Advanced
Qianqian Cheng，JNJ, 成倩倩
13:40 - 14:00
Case sharing of CDASH advanced
14:00 - 14:20
Toxicity Grade Analysis of Healthy Volunteers during ADLB Implementation 关于ADLB实施中健康受试者毒性等级分析
Qianyuan Zhang, JNJ
14:20 - 14:40
Introduction of phuse whitepaper on CDISC data standards, E9 R1
Jintao Shi, BI
14:40 - 15:40
Session 4: Digital Design & Innovation in Clinical Trials
Joy (Qingna) Li, Xiyuan Hospital, 李庆娜
14:40 - 15:00
Implementation Platform and Practice of Remote Intelligent Clinical Trials 远程智能临床式验的实施平台和实践
Li Gaoyang, Lingyan Innovation 李高杨, 羚研创新
15:00 - 15:20
Current Status and Challenges of DCT Applications DCT 应用现状和挑战
Ji Meng, Head of Innovative Business, Chuangda Pharma 蒙技, 创达医药创新业务负责人
15:20 - 15:40
基于Python的cSDRG自动化工具开发——实现临床研究文档生成革命
罗义，凯莱英临床（凯诺）
15:40 - 16:10
Afternoon Break
16:10 - 17:00
Session 5: Regulatory
16:10 - 16:35
EMA Presentation
16:35 - 17:00
PMDA Presentation
17:00 - 18:10
Session 6: CDISC Open Source Usage
Stanley Wei, Novartis
17:00 - 17:20
OAK for SDTM and Admir for ADaM
17:20 - 17:40
LiveTFL:基于SDTM, and ADaM，用R-shiny开发互动版TFL，每天刷新EDC data的统计状态，在early phase失败率比较高的studies，可以替代传统CSR。
Chunpeng Zhao, BeOne
17:40 - 18:10
Panel discussion
18:10 - 18:25
Closing Remarks
John Wang, Caidya
18:30 - 20:30