Services > Biometrics

The department of Biometrics is involved in the early phase of a project, the planning of the study design and is characterised by an efficient processing of the relevant study data using database linked packaged software. The department of Biometrics provides following services.

  • Statistical part of study design; sample size estimation
  • Generation of random codes using SAS®
  • PK-Data Evaluation
    • Generation of study specific customised templates
    • Evaluation of PK-parameter using WinNonlin®
    • List based plausibility checks
    • Preparation and table based aggregation of individual data
    • PK-data report including all individual data, tables and graphics
  • Calculation of in-vitro/in-vivo correlation (IVIVC)
  • Statistical Analysis
    • Generation of study specific customised templates
    • Preparation and validation of SAS® evaluation scripts
    • Statistical analysis with SAS®
    • Preparation of the statistical report including all individual data, graphics and source codes
  • CRF-Data Management
    • Generation of study specific customised, database linked templates
    • Electronic acquisition of CRFs using double data entry
    • Plausibility checks, handling and tracking of queries
    • Data integration to the clinical study report