Once your drug is approved by the FDA, you are responsible for post-market monitoring. Your post-market analysis plan includes phase 4 studies which are carried out in the general population among volunteers who supply information for analysis. These data confirm that your product remains effective and most importantly, remains safe in a general population.
Because your product is already approved by the FDA as a drug, these studies are much more cost effective to complete than pre-market research. Our team works with you to ensure compliance with your FDA authorization, collect and analyze your phase 4 study data, and report it in a timely and appropriate manner.