There is plenty of high-level guidance on real-world evidence (RWE) use in regulatory submissions, but sponsors are often left wondering how to put those recommendations into practice. What does it take to transform complex real-world data (RWD) into regulatory-ready RWE? What can be done to help regulators trust your evidence—and approve your submission? We developed a clear step-by-step framework for the preparation of RWD for regulatory submission based on an in-depth review and synthesis of current FDA guidance and regulator feedback to real-world submissions containing RWE.
Key steps include:
Want to learn more about preparing RWD for regulatory review? Connect with our team to explore how to apply our framework to your next submission, or explore our other RWE services.