Innovative Methods. Reliable Results.
Biostatistics
ClinStat offers the complete range of statistical services. Our industry-experienced biostatisticians in collaboration with our clinical SAS programmers deliver high-quality products. Biostatistician at ClinStat with their expertise in special indications and profound understanding of ICH-GCP guidelines and regulatory requirements ensure highest quality work through all stages of clinical development.
Our services in biostatistics
- Statistical planning of clinical trials in accordance with ICH E9 and other ICH, CPMP or FDA guidelines
- Sample size calculation
- Providing random codes (e.g. in form of randomization lists)
- Statistical Analysis Plan including production of shells for TLFs (tables, listings, figures)
- Conduction of statistical analysis
- Missing data analysis
- Support in the validation process of analysis data sets (e.g. ADaM) and programming support for TLFs
- ISS/ISE analysis or expert reports
- Exploratory analyses for publications and marketing
- Contribution/production of biometrical parts of study protocols and integrated reports
- Interim analyses using adaptive designs
- Support of data safety monitoring boards (DSMBs) / Data monitoring Committees (DMCs)
- Independent biostatistician as DSMB / DMC member
- Meta-analyses
- Publication support
- Support for presentations at regulatory agencies
Statistical software
- SAS (statistical programming and analysis)
- R (statistical programming and analysis)
- StatXact (exact statistical methods)
- nQuery (sample size calculation)