Biostatistics
Our biostatisticians play an essential role in the success of our clinical trial management. They are experts in planning,
analysing and reporting of all Phases of drug development, in a wide range of therapeutic areas.
The statisticians take part in:
Sample size and power estimation
Review of statistical sections of study protocol/plan
Analysis Database creation
Preparation of a detailed Statistical Analysis Plan (SAP) in compliance with correct statistical methodology
Statistical analysis and reporting (tables and figures) using CDISC standards such as ADaM and according to SAP
Interim analysis reports if required
Drafting of Statistical Reports or the statistical sections of the ICH Integrated Report
Clinical Study Report reviews
Statistical consultancy and training regarding many clinical research aspects