Phase I Early Clinical Development

Seamless Phase I Programs for Market Success

First-in-human studies are demanding and multidimensional, requiring a finely tuned balance between scientific rigor, patient safety, regulatory requirements and market access strategies.

Orchestrating these disparate elements requires an experienced and dedicated team of experts who collaborate to inform, advise and execute your Phase I studies.

PPD’s dedicated Phase I professionals customize solutions to fit your unique compound, business model and study objectives.

  • Three PPD Phase I clinics with >250 beds, providing services for both healthy volunteer and patient volunteer studies
  • Global network of Phase I research sites with access to special populations and disease indications
  • Traditional and adaptive trial designs
  • Regulatory, market access and drug development consulting

GLOBAL EXECUTION OF PHASE I STUDIES

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PPD Experience

In the past five years, we have conducted more than 340 studies involving more than 15,000 patients and healthy volunteers.

COVERING YOUR PHASE I NEEDS
  • SAD/MAD
  • Drug-drug interaction
  • Bioequivalence/bioavailability
  • Absorption, distribution, metabolism, excretion
  • Organ impairment/dysfunction
  • Pharmacokinetics
  • QTc studies
  • Food effect
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Global Scale with Fit for Purpose Focus
Three PPD

state-of-the-art clinical research units with ready access to healthy volunteers and patient populations

Network of

10 U.S. and eight global Phase I research sites

Unprecedented access

to global patients via PPD’s Accelerated Enrollment Solutions recruitment engine

Regulatory affairs

team assesses and mitigates risk

Consulting services

for asset planning in the earliest stages of development

PPD Laboratories'

world-class expertise and advanced technologies