As Director of Strategic Partnerships and Clinical Solutions, Pamela is responsible for shaping the RWD handling strategy for Rivia's clinical trial data platform. Prior to joining Rivia, Pamela was a Director at Biogen where she was responsible for developing and leading Biogen's RWD / RWE generation activities for regulatory purposes across multiple therapeutic areas. Pamela holds a bachelor's degree in Molecular Biology and Biotechnology, a master's degree in Computer Science, and a PhD in Physics.
Real-world data (RWD) is often collected under real constraints that may include use of limited resources, legacy systems, and competing priorities. It can make accepting RWD quality as-is the path of least resistance. However, sponsors, sites, and data owners can raise the bar without adding burden to patients or providers. Drawing on good, bad, and ugly case studies, this session explores pragmatic ways to apply principles from recent data quality frameworks, GCP principles, and purpose-built infrastructure to strengthen RWD/RWE quality by design without the extra burden.