Sample Size Determination
Sample size determination is performed in the SAS program based on the primary efficacy parameters of the study.
Data Management and Statistical Methods for Bioequivalence Studies
Determination of sample size for bioequivalence studies. Planning data management in accordance with national/international standards in bioequivalence studies. Performing statistical analysis of bioequivalence studies in the SAS program.
Statistical Evaluation of Clinical Trials
Determination of statistical methods in the study protocol. Preparation of “Statistical Analysis Plan”. Performing statistical analyses in the SAS program.
Preparation Statistical Analysis Results Report
Preparation of the "Statistical Results Report" containing the statistical analysis results in accordance with national/international standards.