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The Active Ingredient features expert insights and commentary from leaders of ZS Associates' global pharmaceuticals practice.

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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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Topics: Pharma, FDA, real-world data, patient centricity, RWE, real-world evidence, pharma companies, RWD, data driven decisions, pharma decision-making

How the Right RWE Platform Serves Up the Ingredients for Innovation

Posted by ZS Editors on Tue, Sep 04, 2018

Many pharmaceutical companies have realized the benefits of moving from standalone real-world data (RWD) projects to full-fledged, cross-functional real-world evidence (RWE) capabilities to drive everything from their R&D programs to their commercial teams’ efforts to demonstrate value—and technology is central to their success. “Real-world evidence is essentially extracting intelligence out of real-world data, and now that we have the right technology, scalable cloud storage and tremendous processing power, we’re actually able to sift through big data to find those insights,” says Abhay Jha, a principal at ZS and the business technology lead in the firm’s R&D excellence practice.  

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Topics: Innovation, R&D, technology innovation, RWE, data and analytics, RWD

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