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Clinical trials

Biostatistics

Statistical planning

  • Operationalisation of study objectives
  • Statistical assessment of the study design
  • Sample size estimation
  • Statistical analysis plan (SAP)

Statistical analysis

  • Interim analysis / data review
  • Blind review
  • Statistical analysis

Reporting

  • Statistical trial report
  • Clinical trial report according to ICH Topic E 3
  • Clinical trial report according to SOPs of sponsor

Statistical service

  • Statistical consulting
  • Statistical programming (SAS)
  • Publications
  • Data preparation for presentations