What Is New Drug Application New Drug Application is to obtain approval for marketing and sale of the new drug after the phase-3 clinical trial. It is a request by the sponsor to the FDA. It is a document that provides animal and human studies…Seguir leyendo
What Is Case Report Form Case Report Form is a specialized tool in clinical research for collecting all data from each participating subject or patient in a clinical trial. The sponsor usually develops or outsources CRF development to collect the specific data they need to…Seguir leyendo