Preclinical
- Clinical development planning
- Regulatory consulting
- Protocol design
- Expert panels
Phase I
- First introduction into 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
Registration/Phase III b
- Individual study reports
- Integrated safety and efficacy summaries
- Treatment INDs
- Package inserts
- Submissions in NDA or CTD formats
Phase IV
- Post-approval regulatory commitments/support for 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
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