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Biostatistics

Biostatistics

Biostatistics play a critical role in every clinical trial. Our team is composed with experienced trial statisticians and industry experts. All statisticians hold a Ph.D. degree with expertise in study design, statistical analysis planning, FDA interaction and regulatory submission. We have extensive experience in multiple therapeutic areas, including oncology, autoimmune diseases, diabetics and neurologic diseases, and more. Beyond the regular biostatistics service, our industry experts can provide unique consultation to innovative study design and respond to FDA/EMA inquiries and submission strategies.

Services include:

  • Trial design (group sequential design, adaptive design and innovative trial design)
  • Sample size estimation (including sample size re-estimation)
  • Development of statistical analysis plan and report
  • Development of integrated summary of efficacy and safety (ISE/ISS)
  • Interim analysis and Data
  • Monitoring Committee (DMC) support
  • Expert consultation on FDA/EMA statistical inquiries and submission strategies
  • Statistical “helpdesk” for immediate consulting needs
  • Publication support and market research