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Phase I studies assess the safety of an investigational drug, device, or procedure. This initial phase of testing usually includes a small number of healthy volunteers. The study is designed to determine its effects on people, including how it is absorbed, metabolized, and excreted.

Phase II studies test the safety and effectiveness of a drug, device, or procedure. This phase can involve up to several hundred participants.

Most phase II studies are trials. One group receives the experimental drug while a "control" group receives a standard treatment or placebo. These studies are often "blinded,” meaning neither the patients nor researchers know who has received the experimental drug. This allows our team to provide the pharmaceutical company and the FDA with comparative information about the new medicine’s safety and effectiveness.

Phase III studies involve several hundred to several thousand participants. This phase provides the pharmaceutical company and the FDA with a more thorough understanding of the safety and effectiveness of the drug, device, or procedure, as well as the possible benefits and range of possible side effects. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the study drug.

Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) compare the new drug with other drugs on the market, (2) monitor a drug's long-term safety, effectiveness, and impact on a patient's quality of life, and (3) determine the cost-effectiveness of the drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug being restricted or taken off the market.