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More Than Statistical Analyses

A Deep Understanding of Every Aspect of Clinical Development Programs:

  • Clinical development planning
  • Study design and protocol input
  • Randomization schedule development
  • Statistical Analysis Plan (SAP) and TFL Shells development
  • Data Monitoring Committee, Evaluation Committee and Interim Analysis support
  • Integrated summary of efficacy and safety (ISE/ISS)
  • Statistical analysis report
  • Regulatory agency interactions and submissions support
  • Publication support and ad hoc analyses
  • Statistical consulting