Utilizing volunteers to study effectiveness and safety, clinical trials, and the participants are essential to advancing new therapies. Clinical research studies are conducted by either the sponsor of the study or a contract research organization (CRO) hired by the sponsor to oversee and manage the study. The process typically starts when a therapeutic device or compound is created by a pharmaceutical or biotechnology company.
In turn, a several years-long stage begins where new therapies are tested rigorously in laboratories to ensure their safety. Very few potential therapies make it through this testing phase, but those that do, move on to the pre-clinical phase, where testing in animals typically occurs.