postmarketregistries “New tools have been emerging allowing companies embarking on trials to do a lot of the work themselves”
Authors:
Ale Gicqueau, Chief Strategy Officer, ClinCapture
  • Learn about the evolution of registry studies.
  • Explore the challenges of the design and data collection.
  • Understand the benefits of using a robust EDC system for this type of study.
  • Gain understanding on the analysis and interpretation of post market registries.
Abstract: At the end of 2012, the FDA approved expanded labeling for the Edwards SAPIEN Transcatheter Heart Valve, making the device available to a larger group of patients with aortic stenosis. This opened a new avenue for device companies to expand indications of approved devices into wider patient populations. The methods needed to achieve these successes require careful planning and development of a flexible and configurable database.