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.