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Our biostatisticians have extensive experience in a wide range of therapeutic areas for Phase I – IV trials. The team thoroughly understands ICH and GCP requirements and carefully follows all FDA and EMA standards and regulations.

We offer:

  • Statistical consulting
    • Protocol development
    • Sample size estimation
    • Clinical study report writing support
    • Publication support
    • Review and validation
  • Statistical analysis plan
    • Statistical analysis plan writing
    • Definition of table shells and fully compliant analysis dataset specifications (ADaM)
    • Analysis plan review
  • Support for data monitoring committees and data safety monitoring boards
    • DMC statisticians
    • Independent statistical DMC analyses
    • Open and closed DMC sessions
    • Blinded interim analyses
  • Regulatory submission support
    • Integrated analysis of efficacy and safety
    • Submission packages
    • Health authority requests
  • Interim analyses
  • Meta analyses