Phase IIIb/Expanded Access

Phase IIIb or peri-approval studies are generally defined as studies that are conducted just before or during regulatory filing and can assist in gaining market approval, provide evidence to support product claims, develop data on the use of a drug or device in an expanded population of patients, and increase the safety profile of a product by demonstrating safety in larger and more diverse populations.

One example of a Phase IIIb study, an Expanded Access program, is used to provide data to develop evidence that an investigational drug, device, or biologic may be effective in special patient subgroups—such as pregnant women, the elderly, children, or patients with other health-related problems—that typically do not qualify for controlled clinical trials. In some cases, the product may be tested on patients who are suffering from a serious or life threatening disease where no other treatment is available. These studies may also generate additional evidence on the safety of the product.

As the importance of Phase IIIb studies grows, so does the importance of having a research partner who knows how to manage these real-world programs, understands what data or evidence regulatory bodies are searching for, and has the capabilities to successfully transition your study from the realm of peri-approval into the world of post-approval. Our experienced team is dedicated to evaluating real-world outcomes in the peri and post-approval areas and manages all aspects of these programs, including clinical program design, statistical analysis, data management, medical monitoring, site recruitment/support/retention, and publications.