A Robust Future for Phase IV Trials


Copyright: This PDF purchase is for a Single user for review or filing purposes only. The PDF is watermarked. If you are interested in a PDF reprint to post on your website or distribute electronically, or hard-copy reprints, please contact Marah Walsh at

SKU: 361. Categories: , .

Product Description

Responsible for approving new therapies while ensuring public safety, the FDA in recent years has frequently mandated that companies conduct late-phase community-based research to evaluate specific safety concerns, sometimes requiring Phase IV studies of newly approved drugs as a condition of approval. This trend, coupled with an increased interest from the pharmaceutical industry to test their products in real-world environments, has spurred rapid growth in Phase IV research activities…

Contributed by Michael Morales, President and CEO, Dimensional HealthCare Inc.