STUDY FOCUS
Built for Early Phase Complexity
The study types I support span the full range of Phase 1 complexity. Phase 1 healthy volunteer through Phase 1b clin pharm patient studies.
01
FIH / SAD / MAD
First-in-human through multiple ascending dose studies with
dose escalation decision support.
02
DDI & Food Effect
Drug-drug interaction and food effect study design, conduct, oversight, and data interpretation.
03
TQTc & rBA/BE
Thorough QT / QTc studies and relative bioavailaility / bioequivalence programs.
04
Human ADME
Mass balance and absorption, distribution, metabolism, and excretion studies in healthy volunteers.
05
Special Populations
Renal and hepatic impairment studies, elderly populations, and ethnic bridging programs.
06
Phase 1b (Patient)
Early-phase patient studies with expanded safety, PK / PD, and proof-of-concept objectives.