A Straight from the Source Webinar Available On-Demand
FDA is encouraging the use of “Digital Evidence” to inform clinical trial design, predict clinical outcomes, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions.
Digital evidence from in silico clinical trials have been shown to produce similar results as human clinical trials and under certain circumstances may replace clinical evidence.
Join FDA’s Tina M. Morrison and Axendia’s Daniel R. Matlis for a live webinar on 18 SEP 2019 at 11:00 AM ET.
We will discuss FDA’s perspective on:
- Shifting from traditional evidence sources to digital evidence
- How to create virtual patients with digital evidence to replace clinical evidence
- Examples of digital evidence in Pharma and Medical Devices used at FDA to initiate and augment clinical studies
- Creating an in silico clinical trial playbook
- Why data in PDF’s are not sufficient
Meet Your Trusted Sources
Register to view this webinar on-demand.