Early Phase Study Design

Early Phase Study Design

Duke Early Phase Clinical Research has the staff and resources to conduct a variety of studies, from proof-of-concept to first-in-human. We leverage the unique capabilities of an academic medical center, adaptive design methodologies, and access to specialized services to conduct healthy volunteer and POC studies.

In addition, we offer invasive and noninvasive hemodynamic monitoring, respiratory and cardiovascular physiology, invasive bronchoscopy, biomarker discovery, imaging, and genomics. Our patients span special populations, including pediatric and geriatric patients.

Early Phase Studies

  • Proof-of-concept (first in patient)
  • Healthy volunteers
  • First-in-human

Complex Research

  • Special populations
  • SAD/MAD
  • Long-term confinement
  • Sophisticated experimental designs

Biological Mechanistic Studies

  • Bioavailability/Bioequivalence
  • Biomarkers
  • Bionutritional
  • Drug-drug and Drug-food interactions
  • Drug metabolism
  • Escalating dose
  • PK/PD/PG
  • Thorough QTc

Imaging Studies

  • CT
  • Functional MRI
  • EchoMRI
  • Nuclear
  • PET
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