Business Unit Overview

Business Unit Overview

Preclinical

  • Clinical development planning
  • Regulatory consulting
  • Protocol design
  • Expert panels

Phase I

  • First introduction to the man
  • PK/PD studies
  • Single-dose, multiple-dose, and dose-escalation studies
  • Special studies (e.g. food interaction; skin irritation)

Phase IIa

  • Proof-of-concept studies
  • Dose-ranging studies

Phase III

  • Large-scale global safety and efficacy studies
  • Placebo-controlled studies
  • Active-comparison studies
  • Bioequivalence studies with clinical endpoints
  • Quality-of-life studies
  • Resource utilization studies

Phase IV

  • Post-approval regulatory commitments/support for the primary indication
  • New indication studies/labeling expansion
  • Medical Information & Professional Contact Center
  • Registries and Observational studies.
  • Health-related quality of life, patient-reported outcomes via IVRS
  • Post-marketing surveillance
  • Product Safety and Pharmacovigilance
  • Retrospective chart reviews
  • Managed-care studies
  • Pharmacoeconomics