Statistically sound.

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.