Biometrics
Our service covers all statistical aspects of pharmaceutical research. This includes the following:
- Planning studies (study design, sample size calculation, determination and definition of primary/secondary endpoints, identification of stratification variables, interim analyses, statistical methodology)
- Finalizing statistical analysis plans
- Performing explorative analyses
- Implementing integrated assessments (Integrated Safety Summaries, Integrated Study Efficacy)
- Preparing blinded data review meetings and independent
data monitoring committee meetings - Specifying and developing analysis datasets (preferably in ADaM format)
- Creating tables, lists and figures
- Providing independent double programming
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