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dMed Sponsored Clinical Data Interchange Standards Consortium (CDISC) China Conference
2017-10-09Return>>
Clinical Data Interchange Standards Consortium (CDISC) China Conference, sponsored by dMed Biopharmaceutical Co., Ltd. (dMed), was held in Beijing on September 21, 2017. dMed's CDISC Expert Team, Dr. Zibao Zhang and Mr. Jun Wang, were presented with CDISC Outstanding Contribution Award.


CDISC Standards make a difference in the quality control of data management and statistical analysis in global clinical trials. On July 27, 2016, China Food and Drug Administration (CFDA) issued "Technical Guideline on Data Management in Clinical Trials". The guidance clearly pointed out that "For new drug marketing applications, it is recommended to use CDISC Standards for original data submission and data analysis." Under the circumstance of Chinese government's great support on regulatory, experts and officials from CDISC Global, CFDA and PMDA conducted in-depth discussions and shared update with representatives from domestic research institutions, pharmaceutical companies and CROs, focusing on implementation of CDISC standards to clinical trials in China.

Mr. Jun Wang, Associate Director of Biostatistics and Programming in dMed and Vice President of CDISC China Coordinating Committee (C3C), conducted a two-day training session to representatives from CFDA-CDE and pharmaceutical companies, explaining in detail the concept and implementation of Study Data Tabulation Model (SDTM).

Dr. Zibao Zhang, Executive Director in dMed and President of Asia-Pacific CDISC Coordinating Committee (AP3C), as the invited guest, participated in several discussions including "Introduction and Update on CDISC Standards".

Mr. Haiping Yu, Technical Operation Lead of Data Management in dMed, made a speech on the theme of "The Advantage to Establish ODM-XML based Metadata Repository".


Mr. Qiang Wang, Senior Statistical Analyst of Biostatistics and Programming in dMed, introduced his topic on "SDRG Automation using R Markdown".


As Ruby Sponsor of this conference, senior leaders of CDISC Global were impressed by dMed's exhibition booth. They expressed that they would further strengthen communication and cooperation with dMed, and they would provide higher quality and standards to support Chinese clinical trials.

After the conference was successfully concluded, Mr. David R. Bobbitt, CDISC President and Chief Executive Officer, presented Mr. Zibao Zhang and Mr. Jun Wang CDISC Outstanding Contribution Award.




With the joint efforts of all parties, dMed will promote the implementation of CDISC Standards and help accelerate the development of innovative medicines and medical devices in China.

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