Phase 1 & Phase 2 Studies

Maximize Data-gathering Opportunities

Phase 1 & 2 studies can individually collect data on early safety, dose selection, and effectiveness trends. Combining the phase 1 & 2 study objectives in one phase 1/2 study maximize data-gathering to answer specific questions.

Our experts advise on the following: 

• Position clients for a successful development plan
• Address “residual uncertainties”
• Preparing for the FDA meetings
• Safety Profile
• PK/PD markers
• Immunogenicity
• Efficacy similarity between your product and its reference