Preclinical/ Phase I
ICON Development Solutions specialises in the strategy and delivery of early phase clinical development.
Preclinical / Phase I
ICON Development Solutions specialises in the strategy and delivery of early-phase clinical development services to enable informed, timely decision making for our clients.
With global clinical pharmacology and bioanalytical presence, ICON offers industry-leading capabilities in early-phase clinical research, bioanalytical/immunoassay, biomarkers, PK, PD, modeling & simulation and the full range of support services.
Key services include:
- Product development consulting
- Protocol design
- Regulatory affairs strategy / submission
- Phase I studies including:
- Food effect studies
- Dosage Regimen assessments
- Diabetic Clamp studies
- QTc studies
- First in man, dose escalation, PK/PD
- Multiple dose studies
- Drug interaction studies
- Bioavailability, bioequivilence
- Phase I patient studies
- Special population studies
- Phase II studies including:
- Patient studies
- Special population studies
- Proof of concept studies
- PK/PD Analysis
- Modelling and simulation