The 2019 Spring Symposium hosted by the North Carolina Regulatory Affairs Forum will be held May 9th, 2019 at the Research Triangle Park Headquarters. Networking will begin at 5:30 p.m., followed by dinner at 6 p.m., and the presentation at 7 p.m.
Given the increasing focus on the use of real-world data in clinical research and regulatory decision-making, this year’s keynote will focus on “Accelerating Clinical Research by Leveraging EHR Data” and will be presented by Dr. Kristen Buck, SVP, Chief Clinical Development for the Life Sciences at Optum.
The pharmaceutical industry is at a tipping point. Clinical trials in the United States have become increasingly more expensive and complex with 70% of clinical trials missing their timelines and 11% of research sites failing to enroll a single patient. Data are abundant and the recent FDA guidances around the use of RWD in clinical research has made the investment in vast clinical data sets even more compelling. By harnessing clinical data, specifically electronic medical record data, and leveraging technological advances, the current clinical trial paradigm can be re-engineered to execute clinical trials that are faster, that utilize fewer resources, and that are more grounded in real world practice.