Patient Safety

Testing new medications must be done in the most careful and ethical fashion. To ensure that occurs all clinical research by MedaPhase on new drugs is supervised by the US Food and Drug Administration. The FDA oversees every aspect of human drug testing, monitoring these studies to ensure that the benefits of the research justify any risks that might arise.

The FDA has the authority to oversee all drug testing activities at pharmaceutical companies as well as at medical facilities like MedaPhase where research is conducted. This oversight includes the right to physically audit research sites, with penalties up to and including felony prosecutions if violations are detected.

MedaPhase is proud that two on-site FDA audits have required no major corrective activities. Our most recent audit returned a rare "no findings noted" review.

In addition to the FDA testing, clinical research testing is also guided by institutional review boards (IRBs). After the terrible experiences with Nazi human experimentation during World War II, the world's medical communities came together to create codes of ethics that guide all human research worldwide. In the United States, human research is supervised by IRBs. These boards include representatives from all walks of life who come together to ensure that research studies do not lead to any unjustified risks to potential subjects. All MedaPhase studies are supervised by established, FDA-supervised IRBs.