PK/PD & Biostatistics

GRC Biostatistics department can assist the sponsor in the design, analysis and interpretation of study data. Our expert biostatisticians have broad experience in various aspects of clinical trials within the drug development arena, from sample size calculation and design issues at the planning stage, to analyzing, displaying and interpreting data in the final stages of the study.

The PK/PD and Biostatistics department at GRC are involved in the study from the initial stages right through to final report. They ensure that the study design and statistical plan are created to answer the study objectives. During the studies they are actively involved in all safety discussions to provide input as needed, correctly determine and assess the PK/PD of your compound from all possible study designs from a population perspective.

The Pharmacokinetic parameters of bioequivalence studies are calculated using Kinetica® 2000 (release 4.4.1), a proprietary software developed and tested for bioequivalence studies. Sample size calculation in clinical trial is done using SAS, PSII. This software performs: non-compartmental analyses of pharmacokinetic parameters and statistical analyses according to FDA, HPFB and EMEA guidance. The Pharmacokinetic parameters of clinical trials Phase II, III and IV are calculated using Access and RDC (Remote Data Capture)