2024 China Interchange Presentation Archive
Session 1: Opening Plenary
Victor Wu C3C, 迪时咨询
Ballroom A
Interchange Opening
Victor Wu (C3C, 迪时咨询)
Welcome Address
Chris Decker, CDISC President and CEO
CDISC Vision: Rebuilding our Foundation and Transforming the Standards Paradigm
Chris Decker, CDISC President and CEO
Delivering a Data-Driven Clinical Protocol - ICH M11
Ron Fitzmartin, FDA-CBER
New CDISC Analysis Results Standard
Bess LeRoy, CDISC
Presentation Files
Document
Session 2: Second Plenary
John Wang C3C, Caidya
Grand Ballroom A
Keynote Presentation: The TransCelerate / CDISC Digital Data Flow; M11
Peter Van Reusel, CDISC Chief Standards Officer
Presentation Files
Keynote Presentation: AI Agent and Its Application in Clinical Data Operations (AI智能体及其在临床数据运营中的应用与思考)
Zhijun (Stanley) Wei, Novartis
Presentation Files
Session 3A: Efficient Start & SDTM
Qianqian Cheng, JNJ
Grand Ballroom A
Implementation of Propensity Score Analysis in Real World Evidence Studies Based on CDISC Standards 基于CDISC标准的真实世界证据研究中倾向性评分分析的实施
Sisi Zhou 周思思, Parexel International
Presentation Files
SDTM Datasets Review Report的实现思路与系统 Ideas and Systems for Implementing SDTM Datasets Review Report
Xuejia Xu 许雪佳, GCP ClinPlus
Presentation Files
SDTM Implementation Guide: An In-Depth Analysis of the Updates and Challenges in IG 3.3 and 3.4 (SDTM实施指南：深入解析IG 3.3和3.4更新与挑战)
Fan Yang 杨帆, Novartis
Presentation Files
Session 3B: End to End Implementation
Yazhong Deng C3C, TrustCRO
Grand Ballroom B
The Value and Practice Sharing of Data Science in Digital and Intelligent Clinical Trials 数字化时代临床试验数据科学价值与应用
Raymone Xu徐海涛, Tigermed泰格医药
Presentation Files
Facilitating Rapid and Accurate Meta-Analysis in Public Health Emergencies: The Role of CDISC Standards in Academic Research
Yen Phan, University of Oxford
CDISC 360项目解读
Qingna Li 李庆娜, 北京西苑医院
Session 4A: Global Regulatory Update & AI
Pamela Chen C3C, Tigermed-MacroStat
Grand Ballroom A
Supporting Submission and Standardisation of Data – an EMA Update
Eftychia-Eirini Psarelli, EMA
Using Artificial Intelligence to Assist MedDRA to Improve the Accuracy and Consistency of AE Records in Clinical Trials人工智能辅助MedDRA提高药品临床试验中不良反应记录的精准性及一致性
Freddy Fei, SAS
Presentation Files
aCRF and SDTM Integrated Automation Tool based on NLP + ML
Shijia Wang, TigerMed
Presentation Files
Session 4B: Safety Implementation
Billy Xin C3C
Grand Ballroom B
Comprehensive Adoption Strategy for the FDA Standard Safety Tables and Figures
Guowei Wu, Merck
Presentation Files
Document
A Novel Approach for the Algorithmic FMQ Analysis Dataset (ADALGFMQ)
Yuanyuan Dong, MSD
Presentation Files
Document
Enhancing Safety Signal Detection: Strategies for Creating FDA Medical Query Analysis Datasets
Huiru Chang, Siru Tang, Danfeng Fu, & Guowei Wu; MSD
Presentation Files
Document
Session 5: CDISC Standards Updates & Submission Preparation
Zibao Zhang C3C, Unionlab
Grand Ballroom A
Digital Health Technologies (DHTs): A Path to Data Standardization
Christine Connolly, CDISC
Presentation Files
TMF Update
Karen Roy, CDISC
Presentation Files
Submission Success: Navigating the Maze of Documentation and Checks for Seamless Regulatory Submissions
Seiko Yamazaki & Julie Ann Hood, Certara
Presentation Files
Session 6A: Preparation for Data Submission 2
Haiquan Sun 凯莱英临床(凯诺)
Grand Ballroom A
AI for Clinical Research and Beyond
Wenjun Bao, JMP
Presentation Files
基于R等多语言开发构建Pinnacle 21报告个性化管理平台：提升数据合规性与效率 Development and Construction of a Personalized Pinnacle 21 Report Management Platform Using R and Other Languages: Enhancing Data Compliance and Efficiency
Mengji Lin 林孟记, 北京方胜远临医药科技有限公司
Implementation and Harmonization End to End CDISC Standard CDASH-SDTM-ADaM in a Platform Trial Framework
Lei Zhang, Boehringer Ingelheim
Presentation Files
Session 6B: Cross Function
Shenglin Zhang 箕星
Grand Ballroom B
Best Practices of Programmers on Master Protocols
Fu Wang, Parexel
Presentation Files
Designing an ADaM Dataset for Streamlined Drug-Induced Liver Injury Screening Analyses
Ben Gao, Danfeng Fu & Guowei Wu, MSD
Presentation Files
Document
ADaM popPK Dataset for NONMEM?? - A Programmer Point of View
Lin Liu, BeiGene
Presentation Files
Session 7A: ADaM Implementation
Haibo Wang 北京方胜远临医药科技有限公司
Grand Ballroom A
Current & Forthcoming CDISC ADaM Publications: An Overview
Guowei Wu & Cindy Stroupe, Merck
Presentation Files
Document
ADRECIST: A Fully Derived Disease Evaluation Dataset ADRECIST：一个完全衍生的疾病评估数据集）
Ping Zhang 张萍, Johnson & Johnson
Presentation Files
Document
创建LB/ADLB过程中遇到的问题和经验总结-案例分享 Summary of Problems and Experiences Encountered in the Process of Creating LB/ADLB - Case Sharing
Shuxin LI 李舒新, 凯莱英临床 凯诺
Presentation Files
Session 7B: SDTM Implementation
Ari Gao, MSD
Grand Ballroom B
Do's and Don'ts for CRF Mapping
Alice Liu, Hengrui Pharmaceutical Company
Presentation Files
Tips About Data Not Collected in cSDRG for Define.xml v2.0/v2.1 关于未采集数据在cSDRG中的呈现
Sophia Ye 叶谦颖, Parexel
Presentation Files
Application Experiences in SEND Data Submission-Analysis of Similarities and Differences Between SEND and SDTM Generation
Chaojun Wu, 凯莱英临床 凯诺
Presentation Files
Session 8: CDISC, AI & Future
John Wang C3C, Caidya
Grand Ballroom A
CDISC China update and Knowledge Frame of Clinical Data Science
Victor Wu, C3C 迪时咨询
Presentation Files
Panel Discussion: CDISC, AI & Future
Interchange Closing