Clinical studies

Strategic statistical planning of individual clinical studies and/or clinical development programs in the context of your development project and/or related clinical studies:

• Statistical support for the design and preparation of clinical development programs to gain fast and efficient approval

• Statistical study planning of, but not limited to, Phase II, III, IIIb, IV and proof-of-concept studies according to current guidelines (ICH-GCP, region-specific guidelines (EMA, FDA)), support in the
  

• selection of primary and secondary endpoints and definition of statistical hypotheses
• choice of study design (parallel-group or cross-over, blinding, randomization, etc.)
• choice of study variables, scales and covariates
• choice of methods and statistical tests for the analysis
• identification of confounding factors
• estimation of the sample size (power calculation)
• provision of the statistical chapters of the study protocol
• provision and/or review of the statistical analysis plan
• review of analysis results on consistency and plausibility
• interpretation of the results
  
• support of the scientific reporting (clinical study reports)
  

• Independent statistician in data (safety) monitoring boards/committees according to current guidelines (see EMEA/CHMP/EWP/5872/03 Corr)

• Core completences diagnostic studies (blinded reads etc.) and oncology.