Phase IV clinical trials are conducted to gather more information on an approved product. In the pre-market approval environment, a Phase IV study is carried out in the population and indication the product is currently approved for, and at the same or lower dose than the approved label dose. These studies are often done to gain additional safety information, information on metabolism, mechanism of action, or other attributes. The advantage of Phase IV studies is the need for only ethics approval, reducing the overall project timeline.
Nutrasource can assist with document and protocol preparation as well as management and execution of clinical trial operations through data analysis and reporting. Through our global network of over 200 sites, we can manage your Phase IV clinical trial needs for a variety of markets, regulatory categories and health indications.
Learn how we can help you run an efficient Phase IV clinical trial that meets your goals.