3. BIOMETRICS AND REPORT WRITING OF CLINICAL STUDIES

Kinesis can analyze and report the kinetic (and dynamic) data of clinical studies. This can be done on data from studies coordinated by Kinesis (see Project coordination) or on data delivered directly by the sponsor. The analysis is done by fully trained Data Analysts under supervision of an experienced Manager Clinical Pharmacokinetics (hyperlink naar www.kinesis-pharma.com).
The data analysis and medical writing occurs according to high quality standards. GCP, GLP or GLP-like procedures will be followed, depending on the preferences of the sponsor. (hyperlink naar www.kinesis-pharma.com.) The

WinNonlin software program of Pharsight is used for the non-compartmental analysis of the pharmacokinetic data (E.g. calculation of Cmax, T1/2, AUC). The program is also used for the statistical analyses including bioequivalence statistics (average, population and individual approaches). Compartmental analysis or evaluation of pharmacokinetic-pharmacodynamic relationships (PK/PD) is also part of our biometric services. More complex analysis, e.g. population pharmacokinetics and clinical trial simulation is done by LAP&P (see Population PK/PD modeling).

The reporting of the study results is done according to our report template or according to the template provided by the sponsor. Kinesis can deliver a fully integrated trial report or only the pharmacokinetic part as a stand-alone report, that can be subsequently integrated into the clinical research report (CRR) written by the sponsor. See also our site about drugdevelopment.

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