We have only just begun to scratch the surface of the potential of the electronic medical record (EMR) to support research and evidence generation in the realm of drug development. During this discussion, we examine several practical applications of real word data from EMRs to support research.
Population-based RWD are increasingly used by US and EU regulators to complement passive safety surveillance that is based on review of adverse event spontaneous reports. The presentation focuses on a recommended analytic approach for safety scientists, epidemiologists, and other researchers for evaluating the causality of a signal identified from one or more data sources.
Virtual study designs are transforming the way biopharmaceutical businesses conduct research. Tactics that decentralize the approach to clinical and observational research are ushering in a new paradigm of efficient data collection and patient centric engagement.
UBC’s Natalie O’Donnell, Executive Director, SERRM, provides a Risk Evaluation and Mitigation Strategy (REMS) overview. Learn more about the importance in partnering with an experienced REMS team for your next study.