The Clinical Bundle is a dedicated package for statistical analysis of clinical equivalence studies of drugs, substances, or more generally various treatments. This package ensures convenience, efficiency, and compliance with regulatory recommendations (EMA, FDA). It streamlines the entire process and covers the whole statistical analysis, from the planning phase to the analysis of the obtained data.
The Clinical Bundle is add-on to Statistica and uses Statistica as its computational environment, providing access to a comprehensive range of analytical methods.
User benefits
- Comprehensive support for data analysis during equivalence studies, including verification of data against assumptions and execution of key analyses with a statistical test indicating whether equivalence is the case or not
- Automation and acceleration of analyses
- Reliability and precision of results
- Easy use and flexibility
Key features
Nine study designs
- R, T
- RT, TR
- RTR, TRT
- RTTR, TRRT
- RTRT, TRTR
- RRT, RTR, TRR
- RTT, TRR
- RRT, TTR
- RRTT, RTTR, TRRT, TTRR
R – Reference, T – Test
Serial measurements analysis
- AUC and its cognates
- Maximum concentration
- Maximum concentration time
- Half-life
- Elimination constant
Analyses
- Sample size estimation
- Power analysis
- Random assignment to groups
- Shapiro-Wilk test
- Levene’s test
- Tukey’s test
- Grubbs’ Test
- Schuirmann’s test (TOST)
- Anderson-Hauck test
- Wilcoxon’s test
All modules run on top of Statistica as their computational environment.
How the module works
Interested?
Clinical Bundle: We will prepare a quote for the module
The module runs on top of Statistica as its computational environment. Tell us which licence you have — we send the quote within one business day.