Tuesday, April 7, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
More pharmaceutical companies are working to understand how real-world evidence can strengthen their submission packages and identifying opportunities to do this across their portfolios. Pragmatic trials that combine the benefits of randomized controlled trials and real-world research are emerging to produce evidence that is fit for regulatory purposes and more. Innovative long-term follow-up methods drive efficiencies, particularly for gene therapies. External comparators provide context for clinical trials including submissions of single-arm trials. Regulatory agencies have signaled increased receptivity to the use of real-world evidence (RWE) in regulatory submission in both the U.S. and global markets.
Register for this Webinar to hear first-hand from a unique combination of real-world experts focused on hybrid study designs who have achieved regulatory success in bringing innovative methods forward.
Three Key Takeaways:
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