FMD NEWS

NEWS

10 October 2017

FMD K&L Biometrics team President Dr. Tiepu Liu, Associate Director of Statistical Programming Dr. C

FMD Biometrics team was excited to participate in the 2017 CDISC China Interchange conference held in Beijing on September 21 and 22.

 

The theme of this year’s meeting is “Empowering Innovation through Standardization” that sums up very well what’s going on in China in the pharmaceutical industry and regulatory policies. As China joins ICH and brings up processes and standards to coordinate efficient global pharmaceutical product development and regulatory review, many opportunities come up, thus CDISC standardization becomes a critical and timely hot topic.

 

During the conference, FMD’s biometrics leaders shared our experiences in this subject area. Dr. Tiepu Liu, President of Global Biometrics, presented history and practice of regulatory guidance in adopting CDISC standards. Chao Wang, Associate Director of Statistical Programming, shared experience in implementing Define.XML in China studies. The speakers shared their insights in implementing CDISC in NDA/BLA submissions.

 

CDISC, Clinical Data Interchange Standards Consortium, as a global, nonprofit organization, develops data standards to streamline clinical research and enable connections to healthcare. Ever since the US FDA planned and later requires data submission for regulatory review and approval, standardizing data format for submission has become a major focal point for sponsors. Recently China FDA has recommended data submission for product reviews and CDISC standards will play a major role in submission format to expedite review time and improve quality.

 

Major benefits to implement CDISC standards include:

  • Fostered efficiency

  • Enhanced innovation

  • Facilitated data sharing

  • Increased predictability

  • Complete traceability

  • Improved data quality

  • Reduced costs

  • Streamlined processes

 

FMD has been a pioneer in adopting CDISC standard in data and analysis and delivery. We have been a gold member of CDISC since the very beginning of CDISC initiative. Our senior leadership team was intimately involved in the first draft of SDTM Implementation Guide and pilot project testing. Over the years, we have provided many training sessions to our global clients. FMD has established in-depth knowledge and hands-on experiences that will undoubtedly make important contributions in the coming years as China starts implementing CDISC standards in its electronic regulatory submissions and reviews.

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