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Westat biostatisticians are experienced in identifying and addressing the relevant statistical issues and developing a detailed analysis plan early in the clinical development stage. This approach assures an appropriate study design, so that sample size requirements, patient selection, and statistical analysis plans are in line with the clinical development schedule. In collaboration with FDA reviewers, Westat has developed new, innovative statistical designs and analysis methods that improve the efficiency and cost effectiveness of clinical programs.

Services:

  • Clinical trial design/development of statistical analysis plan
  • Preparation of biostatistical section
  • Statistical programming & validation
  • Preparation of statistical reports & summaries
  • Interim analyses
  • Preparation of safety & efficacy summaries
  • DSMB support
  • Meta-analyses
  • Support for preparation of NDAs, BLAs, & PLAs
  • Statistical consulting
 
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