Solutions
Clinical Biostatistics
Domain of expertise of our Biostatistics Team covers the full package of statistical consulting solutions and statistical programming required in Phase I-IV trials in various therapeutic areas:
- Study design
- Data mining methodology
- PK analysis
- Development of protocols, incl. sample size and power calculation
- Randomization and integration with IMP management, IVR and IWR systems
- Statistical Analysis Plan creation
- Statistical analysis and consulting (incl. interpretation of statistical results)
- Interim Analysis Reports
- Integrated Clinical Study Report and standalone statistical reports
- Data integration across studies
- ADaM datasets preparation
- SAS® programming, including:
- Analysis Database/ SAS Datasets
- Data tables and listings
- Graphical Data Presentation
Therapeutic Areas
