Ramping Up Real-World Evidence: Assessing the FDA’s New RWE Framework

Posted by Qin Ye on Thu, Jan 24, 2019

Ishita Srivastava and Divya Babbar co-authored this blog post with Qin Ye.

The FDA considers the use of real-world data and real-world evidence a top strategic priority, and on Dec. 6, it unveiled its much-anticipated RWE framework to support the development of drugs and biologics. The framework is aimed at evaluating the potential use of RWE for assessing a product’s effectiveness and focuses on increased stakeholder engagement to effectively leverage RWD and RWE for public health purposes.


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Three Emerging Themes From SCOPE 2017

Posted by Qin Ye on Wed, Feb 01, 2017

As the abundance of patient data continues to grow, the healthcare industry is continuing to find innovative ways to employ it. At the eighth-annual Summit for Clinical Operations Executives (SCOPE) held Jan. 24-26, attendees from across the life sciences space gathered in Miami to discuss how this abundance of data can be used specifically to improve clinical and observational research.


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