Our customized study designs include :
- Efficacy / Proof of Concept (POC) studies
- First in Human (FIH)
- Single ascending dose (SAD) and multiple ascending dose (MAD)
- Adaptive Integrated Clinical Designs (SAD/MAD)
- Safety and tolerability in healthy volunteers, selected special populations and patient groups
- Food effect, Age effect, Gender effect, PK/PD
- QTc studies
- Drug/Drug Interaction studies
- Bioequivalence and comparative Bioavailability studies
Recruiting is crucial to the clinical trials process. Our effective approach to recruitment is two-fold.
Pharmacokinetics and Pharmacodynamics
Our team provides extensive pharmacokinetic (PK) and pharmacodynamic (PD) support in preclinical and clinical studies.