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