Clinical Research

Clinical Research is a critical link in the process of developing new medications and treatments. Development begins in the laboratory where new compounds are designed and created.

Lab research is invaluable to identify the potential of new treatments for diseases we have been fighting for years–but labs can only go so far. The real trials only happen when researchers are confident that there’s a chance their drug can change the industry, and those trials involve people who have very real diseases.

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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.

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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.

Institutional Review Board

In addition to the FDA testing, clinical research testing is also guided by institutional review boards (IRBs).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.

RESOURCES FOR CLINICAL TRIAL INFORMATION

These organizations provide a great deal of information for patients.

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psoriasis
searchclinicaltrials
eczema
ACRP
clinicaltrials.gov
centerwatch
AAD

ONGOING STUDIES

We’re conducting studies in a variety of areas. If you’re interested in participating fill out the form below or click the indication to learn more.

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