The following biometrics services are proposed:

• Statistical support for drug development plan
• Clinical trial design & protocol development:
  • Setting up objectives and estimands framework
  • Clinical trial modeling and simulation
  • Adaptive and fixed designs in Bayesian and frequentist framework
  • Sample size determination, power and assurance calculation
  • Statistical input for protocol
• Randomization
• Statistical analysis plan:
  • Description of statistical analyses and data summaries
  • Creation of shells for out-text and in-text tables, figures and listings
• Peer review of other related clinical trial documents:
  • Charters, ICF, IWRS, data management & programming documents, …
• Statistical analysis and reporting:
  • Creation of out-text and in-text tables, figures and listings
  • Statistical input for clinical study report
  • Statistical support for publications
• Interim Analyses
  • Data monitoring committee support and participation
  • Production of interim analysis output

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