Our experienced Pharmacokineticists offer non-compartmental and compartmental analyses and PK/PD analyses.
Our experience includes performing final analyses for PK endpoints as well as providing continuous PK reporting throughout a trial to assist sponsors in decision-making, e.g. for dose-escalation decisions.
For our Pharmacokinetics we use Phoenix WinNonlin® and SAS® software.
All analysis and reporting are based on FDA, EMA, and ICH guidelines, following trial needs as well as Biotrial/Sponsor SOPs.
Oversee and manage PK-related elements of a project including protocol development, analysis plan, calculation of PK parameters, PK report writing
In charge of all PK biostatistics activities on a given project, oversee programming of PK datasets and TFLs, discuss results with Pharmacokineticist
In charge of the programming of the SDTM & ADaM datasets and statistical PK TFLs
