Comprehensive Biostatistics Support Services

Design, Conduct, Analysis, and Reporting


Study Design

  • We support frequentist and Bayes designs
  • We support Phase 1, 1/2, 2, 2/3, 3, and post market surveillance studies
  • We conduct simulations to assess Type I error and power
  • We develop strategies to control the overall Type I error
  • We support all randomization types
  • We develop SAPs including table, listing, and figure specifications
  • We propose composite endpoints
  • We perform analyses to support performance goal metrics
  • We perform sample size calculations
  • We write the protocol statistical considerations sections
  • We propose hierarchical testing plans

Study Conduct

  • We support DSMB meetings
  • We support CDISC submissions
  • We develop interim monitoring plans
  • We assess pharmacovigilance

Data Analysis

  • We perform interim analyses
  • We perform final analyses
  • We develop models
  • We conduct meta analyses
  • We offer second and third opinions on completed studies


  • We defend products at FDA meetings and agency hearings
  • We prepare effective presentations to best defend product efficacy, safety, and risk-benefit
  • We are comfortable interacting with senior management, partners, and investors
  • We support abstracts, publications, and presentations