Early Phase
Proof of Concept
These types of studies are very crucial in deciding if the drug moves ahead in the development process. This also plays an important role in deciding the design of the Phase II trial. Our expertise in other areas such as Regulatory and Scientific Areas allow us to design and implement Proof of Concept studies for new drug entities across a broad range of therapeutic indications.
Our team offers customized solutions including the appropriate use of biomarkers and adaptive trial designs. Pharmacodynamic markers can often be shown in healthy volunteers. These same markers correlate with a therapeutic response when the drug is administered to an affected individual. This allows valuable drug-response information to be obtained from Phase I studies.
