ICON has extensive experience in the design of early clinical development plans up to proof-of-concept, and in the design, study conduct and interpretation of clinical pharmacology studies including a selection of pharmacodynamic biomarkers tailored to the asset.
Across all elements of your program from development plan, and study synopsis to CSR, we apply integrated medical, scientific and operational excellence that’s dedicated to early phase development essential to reaching decision milestones on-time and with the highest quality insights.
Design
ICON’s consultancy services offer advice on clinical pharmacology study design based on preclinical data including potential surrogate markers and pharmacodynamic models, validation of those markers and models, clear objective setting, and flexible protocol design.
We offer outcome-oriented thinking to help make critical development decisions early in the process. The extensive experience of our scientists and medical staff will ensure that the most appropriate and cost-effective program is designed for your compound development.
Implementation
Once the correct study design has been agreed there is rapid transfer and start-up of the clinical phase.
ICON has experience implementing:
- First-in-Human, dose escalation studies, including QTc concentration-effect modeling
- Drug interaction studies
- Mass balance studies and absolute bioavailability studies with 14C-labeled drug
- Special population studies (pediatric PK, elderly, renal-impaired, hepatic-impaired)
- Thorough QTc studies
- Dose proportionality
- Multi-dose PK and/or PKPD
- Age/Gender/Race/Ethnicity
- Food effect studies
- Relative bioavailability (including formulation bioequivalence)
- Dosage regimen assessments
- Challenge studies, incl. with tyramine, allergens, and LPS, and other challenge agents as the asset may require.
- Pharmacodynamic studies with tailored biomarkers, and surrogate endpoints, including imaging, cerebrospinal fluid markers, bone marrow aspirate markers, spirometry, and a further suite of markers as the asset may require.
Interpretation
ICON provides quick, accurate support to aid decisions made about your molecule. With in-house bioanalytical and clinical pharmacology laboratories, ICON is able to provide real-time analysis of samples for quick decision-making. With in-house data management, biostatistics, pharmacokinetics and clinical pharmacology staff in the US and in Europe, we are able to provide expert, regulatory-ready data analyses and reports.