Statistics

• Statistical input to trial protocol
• Power and sample size calculation
• Statistical analysis plan
• Randomisation code generation in SAS
• Pharmacokinetic and pharmacodynamic analysis in WinNonLin
• Fully validated SAS programs and macros to calculate bioequivalence, ANOVA/ANCOVAs, and other comparisons
• All statistical tables and listings are based on validated programs and according to ICH E3 guidelines
• Pharmacokinetic, pharmacodynamic, and statistical reports