PRODUCT DEVELOPMENT SERVICES
Access to unrivaled expertise

The clinical pharmacology team at ICON Development Solutions has extensive experience in the design, implementation and interpretation of clinical pharmacology studies in all major therapeutic areas.

Design: consultancy services offer an input to preclinical packages to determine potential surrogate markers and models; validation of surrogate markers and models; clear objectives; flexible protocol design. We offer clear thinking to help make critical development decisions quickly and with a high degree of confidence.

Implementation: once the correct study design has been agreed there is rapid transfer and start up of the clinical phase. With the incorporation of Medeval Ltd into the ICON group of Companies, we have one of the world's most innovative Phase I units. With a focus on early clinical development, we can undertake First in Man (FIM) studies almost routinely, on average taking one new chemical entity into man every month.

With a clinical operations team experienced in the unique needs of Phase I-IIa studies and access to other facilities in the US and Europe for healthy volunteer, patient and special population studies, ICON is well-positioned to fully implement early phase clinical development programs:
  •    First-in-Human, dose escalation, PK, PD
  •    Multiple dose studies
  •    Drug interaction studies
  •    Bioavailability, Bioequivalence
  •    Pharmacodynamic studies
  •    Biomarkers, Imaging
  •    Phase I-IIa patient studies
  •    Special population studies
Interpretation: 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.