The U.S. Food and Drug Administration (FDA) recently released a new framework for implementing its Real-World Evidence (RWE) Program. Under the updated framework, the FDA has defined RWE as the “clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of” real-world data.

IVRCC builds and deploys configurable applications to facilitate the compilation and analysis of retrospective EMR data.  Find out how we do it and how our technology supports this important medical work and the FDA’s Real-World Evidence Program – contact us today to learn more at or 561-789-4890.

Learn more about the new framework and how it may affect affect clinical studies and clinical data collection

View the FDA’s Real-World Evidene Program Framework (PDF)