Clinical Research Process in SAS Clinical

Clinical trials are prospective studies on human subjects that are designed to answer specific questions about drugs, treatments, devices or new ways of using known interventions, generating safety and efficacy data.

Clinical Research is a study that tests how well an intervention works in a group of people, Tests for new methods of screening, prevention, diagnosis, or therapy. During a trial, additional information is learned about an intervention, its Risks, and its effectiveness.

Clinical Research Process

♦ Pre-clinical testing

♦ Investigational New Drug Application (IND)

♦ Phase I (assess safety)

♦ Phase II (test for effectiveness)

♦ Phase III (large-scale testing)

♦ Licensing (approval to use)

♦ Approval (available for prescription)

♦ Post-marketing studies (special studies and long-term effectiveness/use)

Pre-Clinical Testing

Pre-clinical testing is required before testing humans. Pre-clinical testing is often conducted on animals many pre-clinical studies use a review Committee to determine if the use of animals is warranted. The review Committee also checks to see if the research can be improved by reducing or replacing animals. Laboratory and animal studies are conducted to find out if there is a potential benefit of the drug, vaccine, or other product and to explore general safety concerns. If a vaccine, Drug has a potential benefit, it is prepared for human testing.