Phase 3 is an exciting, but critical time. As your product nears the finish line, the required studies are larger and more complex, leaving little room for error. The FDA requires these studies after phase 2 studies have demonstrated efficacy. After completion of sufficient phase 3 studies, a new drug application (NDA) can be submitted for drug authorization.
These studies are also used to support prevention claims and structure/function claims for non-drug products. They build upon the work completed in phase 2 studies and feasibility studies, and allow us to identify how your product compares to the standard of care, how it interacts with other treatments, and what rare reactions might exist.
This critical stage of your project requires a unique blend of expertise to ensure that the findings from phase 2 studies are replicated in a larger scale with a more diverse population. It is not uncommon for phase 3 studies to fail to find the results identified in phase 2 studies. Our team can work with you to develop studies build around your product’s features to meet FDA standards.
Our team also manages expanded participant recruitment, timelines, complex databases, and FDA updates. We accomplish this by developing studies specifically around the findings of your phase 2 studies, feasibility trials, and other existing evidence to protect your investment.