Datasheet | February 13, 2012

Early-Phase Metabolic Development Datasheet

Source: ICON

ICON's consultancy services advise on clinical pharmacology study designs based on preclinical data – including potential use of surrogate markers and pharmacodynamic models, validation of those markers and models, clear objective setting and flexible protocol design. 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.

Strategic Consulting for Metabolic Therapeutics

  • Protocol Review
  • Protocol Synopsis/Protocol Development/CSRs:
    • Phase I development plans for diabetes therapeutics, including design, conduct, evaluation and reporting
    • SAD and MAD protocol development that incorporates serial glucose measurements in healthy volunteers for an early evaluation of potential drug effect
    • Strategic advice and guidance on the appropriate inclusion of pharmacodynamic techniques that can accelerate the development process for metabolic products or enable faster go/no go decisions on compound development