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Statistical Services

We have highly qualified statisticians with extensive experience working with the FDA.

  • Statistical analysis sections of protocols
  • Statistical analysis plans
    • SAP following ICH guidance
    • SAP following your template, if you wish
    • Mock tables included in separate document
    • Tables manuals (developed with programmers and data managers) in separate document
  • Review of SAPs
    • For statistical soundness
    • For conformance to ICH guidelines
    • For conformance to FDA expectations per published guidance
    • For technical readability
    • For internal consistency
    • For consistency with protocol
  • Review of sample size determinations
  • Review of statistical analysis
  • Statistical review of report
  • Statistical review of tables, figures, and listings
    • For quality assessment
    • For story
    • For analysis
  • Statistical reporting
  • Plans for meta-analysis
  • Plans for integrated analysis of efficacy
  • Plans for integrated analysis of safety
  • Plans for statistical parts of common technical document

 

 

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