BIOSTATISTICS

All clinical trials are data factories — but there’s much more to a successful trial than data. Through thoughtful organization and interpretation, our biostatistics team turns raw numbers into information that drives decisions and lays the foundation for progress that moves your product forward.

IICRT's biostatisticians work with you to determine the optimal methods for collecting, analyzing, and presenting data, while maintaining compliance with regulatory guidelines. Solid statistical analysis starts with careful planning and carries through analysis and reporting, so we work with you starting from protocol design and sample size calculation through CSR writing and review.

  • Clinical Trial Design.
  • Protocol Development.
  • Sample Size Calculation.
  • Client Representation at Regulatory Agency.
  • Randomization Schedule Preparation.
  • Statistical Analysis Plan (SAP) Development.
  • SAS Programming and Independent Validation of Tables, Listing and Figures.
  • Interim Analysis Planning.
  • PK / PD Analysis.
  • Statistical Reporting.
  • Development and Review of Clinical Study Report (CSR).

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