Design

Preclinical consultancy services to determine potential surrogate markers and models; validation of surrogate markers and models; development of flexible protocol design.

We offer clear thinking to help make critical development decisions quickly.

Implementation

Once the correct study design has been agreed there is rapid transfer and start up of the clinical phase. We undertake First in Man (FIM) studies, on average taking one new chemical entity into man every month.

ICON has experience implementing:

• First-in-Human, dose escalation studies
• Drug interaction studies
• Special population studies (pediatric PK, elderly, renal-impaired, hepatic-impaired)
• Thorough QTc studies
• Dose proportionality
• Multi-dose PK and/or PKPD
• Age/Gender/Race
• Food effect studies
• Relative bioavailability (including formulation bioequivalence)
• Absolute bioavailability
• Dosage regimen assessments
• Pharmacodynamic studies

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.