Innovative Methods. Reliable Results.


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)