Shanghai (Nov 12 - Nov 13, 2021)

Application Development & Technical Techniques Coder's Corner Data Validation & Management Data Standards/CDISC and Regulatory Submission

Data Visualization and Graphics Management and Career Development Statistics & R

Application Development & Technical Techniques

AD03. Data De-identification of Demographic Detail in Adult and Pediatric Study
Huan Lu, Sanofi Aventis

AD08. Risk of Re-identification Assessment
Lanlan Peng, Sanofi Aventis

AD11. Auto-annotation in SDTM aCRF Using R Package and SAS
Teresa Tang, Merck

AD13. A Tool to Combine TFL Outputs
Jason Wang,Yashan Zhou, WuXi Clinical

AD14. Development of Integrated Statistical Computing Platform (iSCP) Based on Intelligent Apps
Zhiping Yan, Dizal

AD20. Title/footnote Auto Extraction from TLG shell to Program Tracker
Jiapeng He, Tingting Zeng, BeiGene, Beijing

AD32. A Submission Package Translation Toolkit by SAS and Excel VBA
Shijia Wang, Tigermed Co., Ltd.

AD35. CRF Chinese Translation – Mask Plan
Chunpeng Zhao, Liming Xie, Chunling Xu, BeiGene

AD40. Automation for CRF Annotation and Bookmark Generation via Python
Peng Wang, Yiqun Wang, Cstone Pharmaceuticals

AD42. Essential project management skill for solving potential risks of electronic study data submission to PMDA
Manabu Uehara, Takashi Kitahara, Novartis

AD44. ISPP, an Integrated Statistical Programming Platform to systematically manage study programing environment, program, output, log, lst and more
Jinling Li, BeiGene

AD45. AUTOMATING SAS EG INTEGRATION TECHNOLOGIES VIA EXCEL VBA
Xiaoyang Yu, Anheart Therapeutics(Hangzhou) Co.,Ltd.

AD49. An Approach to Generate Define.xml for Submission in China Based on Python
Siyi Li, Sanofi Aventis

AD61. Leveraging Python Streamlit to do project management
Zhiwei Luo, Pfizer (China) Research and Development Co.,Ltd. China

AD67. SDTM ARTs - a CRF-Driven SDTM Automation Tool for Generating aCRF, SDTM Mapping Specification and Programs
Haiqiang Luo, Kaiying Li, Xiaoyi Niu, Xiaoxia Zhou, Hengrui Pharma, Guangzhou, China

AD72. Using R Shiny to Explore Clinical Trial Data
Yaoxian Yuan, Jiaying Wu, CStone Pharmaceuticals (Suzhou) Co., Ltd

AD75. Automated Process from aCRF to ADRG for SAS programming with Python and VBA
Weineng Zhou, Parexel International, Shanghai, China

AD101. Multi-study programming – a best practice outline
Simon Purkess, Matt Metherell, PHASTAR, London, UK

Coder's Corner

CC04. TFLS TITLE CHECK TOOL
Beixin Lu, BeiGene Co., Ltd.

CC15. How to Translate RTF Documents
Jundong Ma, Zhiping Yan, Dizal Pharma, Shanghai, China

CC26. Surviving Left Truncation: Number at Risk Calculation for a Specific Timepoint Using SAS
Rolland Luo,Lihua Wu, Sanofi Aventis

CC53. A SAS Macro to Generate Customized Patient Profile Output Simply
Mingyue Zhu, Everest Clinical Research

CC65. Customize EXCEL Output
Hui Liu, Jiangsu Hengrui Pharmaceuticals Co.,Ltd., Guang Zhou

CC73. Float-point number and encode in SAS
Weineng Zhou, Parexel International, Shanghai, China

CC76. Estimating Binomial Proportion Confidence Interval with Zero Frequency Response using FREQ Procedure
Linga Reddy Baddam, Syneos Health®, Hyderabad, India

CC81. The Hidden Influence of Program Structure in the SAS DATA Step
Xiangyu Song, Laekna Therapeutics

Data Validation & Management (DM)

DM16. Quality Management of Critical Data from eDevice in Decentralized Clinical Trial
Yueqing Wang, Binqi Ye, Boehringer-Ingelheim, Co. Ltd

DM18. Don’t Panic: A Data Manager’s Guide to SDTM
Lanjin Jin, Boehringer-Ingelheim, Co. Ltd

DM23. Implementation of Data Cut-Off in Analysis of Oncology Clinical Trials
Shang Shi, Weibin Cai, Zhiping Yan, Dizal Pharma, Beijing, China

Data Standards/CDISC and Regulatory Submission

DS07. A Customizable Conformance Check Tool Design
Dan Li, Merck; Haiping Yu, dMed Biopharmaceutical Co., Ltd.

DS09. SAS Macro Solution for NMPA Submission Data Validation Rules
Ting Sun and Jipian He, dMed

DS33. Consideration and Solutions of Garbled Codes in Multiple Languages Projects
Yi Lu, Shijia Wang, Tigermed Co., Ltd.

DS36. SDTM Annotated CRF Digitalization
Chunpeng Zhao, Mijun Hu, Jiapeng He and Aide Zhou, BeiGene

DS46. Annotated CRF Submission to NMPA for Foreign Database
Shan Wan, Sanofi, Chengdu, China

DS47. Challenges and solutions for e-data submission to NMPA under new regulation
Grace Sun, Astrazeneca

DS51. Coding Data Translation Automation
Chunling Xu, Quting Zhang, Yankun Zhang, Yang Song, BeiGene (Beijing) Co., Ltd.

DS83. How to present exposure data nicely in the SDTM?
Manxi Chen, Everest Clinical Research

DS102. A case of mistaken ID: reimagining rescreenings and reenrollments
Matt Metherell, PHASTAR, London

Data Visualization and Graphics

DV05. Review Response Data with an R Shiny App
Hengwei Liu, Hengrui USA

DV22. SAS Macro to Derive Integrated PET+CT Response in FDG-avid Lymphoma per Lugano 2014
Jia Xu, Wenxiao Zhou, Xiaotong Li, Ziwen Tan, BeiGene Co., Ltd.

DV30. Visualization to detect risks of clinical data in Risk-Based Quality Management
Haitao Xu, Siyi Ma, Xilin Luo, Tigermed Co., Ltd.

DV39. Utilizing Plotly in R to Review Clinical Data with Interactive Plots
Kailu Song, Beigene (Beijing) Co., Ltd.

DV68. Visualization of Oncology Data from Interactive Dashboards
Jie Yue, Harbour BioMed

Management and Career Development

MA70. New Opportunities and Challenges for Statistical Programming Job Position in China Bio-Pharma
Xin Wang, Yu Cheng, Beijing Fosun Pharmaceutical Research and Development Co., Ltd.

Statistics & R

SR31. JSON Data in R
Peng Li, Sanofi Aventis

SR38. A novel insight into confirmed Best Overall Response per RECIST 1.1
Shuangbin Ji, CR Medicon, Nanjing, China

SR41. Number of Events Estimation using R step by step
Chunyan He, Ark Biosciences Inc.; Liyan Zhao, Changchun University of Technology

SR52. Being Therapeutic Area Coach for Programmers: Taking RECIST 1.1 Training as An Example
Han Wang, Jiaqi Wang, Beigene (Beijing) Co., Ltd.

SR55. Statistical considerations in a case study disrupted by COVID-19 pandemic
Kun Li, Jiangsu Hengrui Pharmaceutical Co., Ltd.

SR57. BIP: A Powerful Biomarker Interactive Profiler based on R Shiny APP
Miao Yu, Chun Yi, BeiGene Co., Ltd.

SR66. BRAT: An R-Shiny Application on Block Randomization Allocation Process for Animal Experiments in Clinical Research Area
Shuo Zhang, Chun Yi, BeiGene Co., Ltd.

SR78. The Application of Reference-Scaled Average Bioequivalence in Bioequivalence Analysis with Highly Variable Drug
Chuying Dai, CR Medicon, Nanjing, China

SR79. Interactive web widgets and applications in R
Changming Yang, BeiGene