A comprehensive Statistical Analysis Plan (SAP) is fundamental to running a clinical trial.  Our teams of statisticians and SAS programmers work together with the client to ensure they get the output they need for the clinical trial report.

Working with the client we document and obtain agreement on the following:

  • Primary and secondary objectives, along with any possible changes
  • Sample size, randomization, and blinding
  • Disposition of study participants and definitions of populations: efficacy-evaluable, intention-to-treat, safety, and any sub-groups
  • Interim statistical analysis, methods for handling missing data
  • Demographics and baseline characteristics
  • Compliance to study drug or treatment
  • Method for analysis of efficacy endpoints
  • Evaluation of safety parameters
  • Detailed description of all statistical analyses and data summaries
  • Shell Tables, Figures and Listings (TFLs)

Other Services

Innovative analytics solutions that derive better information from your life sciences, pharma & healthcare data.

Clinical Study Protocol Development
Data Management & Review
Hot House Simulation

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