FDORA FAQs: The Easiest Way To Meet the FDA's Clinical Trial Diversity Requirement

In December 2022, the Consolidated Appropriations Act became law, and within it lies the FDA Omnibus Reform Act of 2022 (FDORA). This legislation carries substantial implications for various aspects of clinical research, including decentralized trial guidance, digital health technology guidance, updates to BIMO inspections, and modifications to the accelerated approval process. Yet, one of the most significant changes ushered in by FDORA pertains to its mandatory diversity action plan requirement, which promises to reshape the landscape of research endeavors in the future.

When it comes to navigating the complexities of FDORA and crafting effective diversity action plans, Elligo is an elite provider. Our PatientSelect® model provides unparalleled access to an extensive database of millions of known patients and their HIPAA-compliant identified healthcare information, all facilitated by state-of-the-art AI technology. This empowers you to precisely pinpoint, identify, and engage with distinct patient demographics, while also offering clinical research as a care option delivered through their trusted healthcare providers.

Learn how this innovative approach not only streamlines the diversity action plan process but also places a strong emphasis on patient-centricity, ensuring that patients are at the heart of the research journey.