case examples

optimize lead selection
Preclinical studies have identified a lead compound that targets a pathophysiology in animal models of a particular disease. The company wants confirmation of the preclinical model in humans.

confirm efficacy
A drug is in Phase II and the company wishes to have an early indication of the drug’s efficacy in the general patient population and an identification of factors that impinge on safety and efficacy, prior to committing resources for further development. The cost of a Phase III study using the acceptable indication specific efficacy criteria will require both time and extensive resources.

market positioning
New drug approved and launched but slow acceptance by physicians. The company wishes to generate accessible and informative clinical data that can be used to inform and educate physicians, managed care providers and patients on the appropriate use of the new drug.