Clinical Research

Clinical research is a branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.The term clinical research refers to the entire biography of a drug from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to pre-clinical studies or animal studies where different aspects of the drug (including its efficacy and toxicity) are studied. In the United States, the data obtained from the pre-clinical studies are submitted as an Investigational New Drug (IND) to the Food and Drug Administration (FDA) for permission to conduct human studies. In the European Union, the European Medicines Agency (EMEA) acts in a similar fashion for studies conducted in their region.

The four phases involved in the clinical research are

Study Design & Protocol Development

Project Management

Site Management

Regulatory Requirements