Introduction A miracle happened for the first time in the history of cancer. For the first time in history, the new monoclonal antibody drug Dostarlimab cured every Colorectal Cancer patient during “experimental immunotherapy treatment”. Finally, Cancer Researchers are able to find cures for cancer. Latest…Read more
Frequently Asked Questions In Clinical Research Que: What is FDA? Ans: The Full form of the FDA is Food & Drug Administration, which is an agent that is in the USA for the health and human service. The role of the FDA is to ensure…Read more
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…Read more
What Is Drug Application There are two broad categories of drug applications controlled by the United States Food & Drugs Administration (FDA): Request for authorisation for clinical investigation Request for marketing approval Investigational New Drug Application comes into the first category of drug application, which…Read more
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…Read more