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Tigermed Biometrics division, the second largest division of Tigermed Group, has a large number of highly qualified and dedicated talents. We provide high quality and professional data management and biostatistics services to support clinical development and regulatory submissions.

Tigermed Biometrics team operates in Shanghai, Jiaxing, Wuhan, Taiwan and US New Jersey to cover Asia Pacific and North America. We have well-established management and SOP systems, and have passed all audits from over 60 clients with no critical findings. We have completed more than 900 projects for over 400 clients so far.

Our Strength – Biostatistics
• Hundreds of experienced and talented people with a low turnover rate and high growth trend

• Senior statisticians with an average of over 10 years of experience, and most of them from  United States with 15-30 years

  experience in pharmaceutical industry

• Expertise in statistical support for regulatory submissions in US, Europe, Australia,  Japan, China and other countries/regions

• Extensive CDISC experience to support global submissions and legacy data conversion, and  CDISC committee membership

  in China and United States

Biostatistics Service Scope

• KOL in China Biometrics society and CFDA Data Standards, and Quality and Biostatics  initiatives
• Provide support and interaction with regulatory agencies
• Clinical trial design and consulting
• Statistical input to protocol development
• Sample size/power estimation
• Randomization schedule
• Statistical analysis plan
• Tables, Figures and Listings (TFLs) Shells
• Statistical programming
• Analysis dataset
• Tables, Figures and Listings (TFLs)

• Full scope of CDISC services: Annotated CRF, SDTM specification and creation, ADaM  specification and creation, CDISC

  validation,  Define.PDF or Define.XML, Study Data  Reviewer’s Guide, Analysis Data Reviewer’s Guide,

  and legacy data conversion

• Integrated dataset and TFLs for Integrated summary of efficacy and safety (ISE/ISS)
• Interim analysis and Data Monitoring Committee (DMC) support
• Integrated summary of efficacy and safety (ISE/ISS)
• Statistical analysis report
• Clinical study report
• Provide statistical support for regulatory submissions
• Provide statistical support for manuscripts and publications in various therapeutic areas