We provide extensive pharmacokinetic (PK) and pharmacodynamic (PD) support – as part of our Biostatistics services – in Phase 1-3 clinical studies in accordance with international regulatory standards (FDA, EMEA, and ICH).

We offer human pharmacology services that include, but are not limited to, single- and multiple-dose PK studies, bioavailability studies, bioequivalence studies, drug-drug interaction studies (DDI), population PK, and PK/PD or dose-response studies.

Additionally, we provide the following related services to our biopharmaceutical clients:

  • Pharmacokinetic study design
  • Consulting and liaison with regulatory agency officials
  • Pharmacokinetic protocol authorship
  • Pharmacokinetic data analysis and modeling
  • Pharmacokinetic clinical study report writing