Head of our PK/Statistics department is Dr. Bernhard Vens-Cappell, an expert in the fields of phase I study design and analysis with more than 20 years of experience. The services include the following:

Medical Writing:

• Preparation and Review of clinical study protocol in compliance with ICH
• Preparation of clinical study reports in compliance with ICH

The Pharmacokinetic services include:

• Study Design
• Bioavailability and Bioequivalence assessments
• Model-dependent or independent estimation of pharmacokinetic variables
• Population kinetics (NONMEM ®)
• PK/PD modelling and evaluation (WinNonlin ®).

The Statistical services comprise:

• Statistical input for planning of clinical studies (e.g. sample size estimation)
• Statistical analysis of clinical data (SAS ®)
• Preparation of statistical analysis plans
• Data reviews, Interim analysis
• Meta analysis.