The Process

Clinical research testing typically occurs in several steps. In some cases, the earliest testing occurs on healthy volunteers to evaluate the safety and tolerability of a new drug. MedaPhase's role begins with Phase II research studies, which are conducted with study volunteers diagnosed with the disease that the drug was designed to treat. These studies are designed to identify the optimal dose and administration of drugs, and secondarily provide the first indication of how effective a drug may be for the disease in question. Drugs that show promise, and which appear to be safe and well-tolerated, will then move into final Phase III testing. These are large-scale studies, typically conducted at multiple sites across the country. The information generated will be used in the actual submission to the FDA for the drug to be formally approved for sale in the United States. Phase II and III studies are the heart of the MedaPhase activity for research.