Biostatistical Design and Analysis

Westat biostatisticians identify and address the relevant statistical issues and develop detailed analysis plans early in the clinical development stage. This approach ensures 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 Food and Drug Administration (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
  • Preparation of protocol biostatistical section
  • Development of statistical analysis plan
  • Statistical programming and validation using SAS
  • Application of a broad range of statistical methodologies in preparation of statistical reports and summaries:
    • Repeated measures analysis
    • Longitudinal analysis
    • Modeling for age-dependent data
    • Surrogate marker analysis
    • Time-to-event analysis
    • Bayesian statistical methods
    • Continual reassessment method for dose ranging studies
  • Interim and final statistical analyses
  • Production of statistical section of final clinical study report
  • Preparation of safety and efficacy summaries
  • Data monitoring committee (DMC) support (statistical/administrative support)
  • Support for preparing:
    • New drug applications (NDAs)
    • Biologics license applications (BLAs)
    • Product license applications (PLAs)
    • Annual investigational new drug (IND) safety updates
  • Meta-analyses
  • Statistical consulting