Dr. Bernhard Vens-Cappell, head of our PK / Statistical department, also contributes with valuable advice to our team of consultants.

He may provide a sophisticated expert opinion with regards to your specific project needs i.e. discussion of your market authorization strategy and the corresponding impacts for your trail planning. Furthermore, he is not only responsible for the evaluation of studies performed in-house but also provides competent scientific and statistical advice to external clients i.e. for deficiency letters from competent authorities.

Naturally, the services offered for in-house trials are also provided to external clients:

The Pharmacokinetic services include:

• 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 ®)
• Development of the statistical part of study protocols
• Preparation of statistical analysis plans
• Data reviews, Interim analysis
• Integrated statistical report
• Meta analysis