Longstanding collaboration with the FDA.
Verantos conducts FDA-sponsored demonstration projects that define how real-world data reliability is measured, and how that reliability shapes the validity of regulatory evidence.
First define the measurement. Then apply it to regulatory decisions.
TRUST
Transforming Real-world evidence with Unstructured and Structured data to advance Tailored therapyTRUST defined methods for measurement of data reliability and assessed the impact of data reliability on evidence validity using those measurement methods. The findings informed the FDA’s 2024 guidance on the use of EHR and claims data to support regulatory decision-making.
→ informed the FDA’s 2024 EHR and claims data guidanceVERIFY
VERIFY acronym expansion to come from VerantosVERIFY assesses the impact of data reliability in real-world applications, specifically focusing on label expansion, extending the TRUST methodology into the regulatory decisions that bring new indications to patients.
→ extends TRUST into label expansionVerantos has conducted high-validity RWE studies for the FDA, the National Institutes of Health, and the National Science Foundation · FDA award U01FD007172 cited in Epidemiology, 2025.
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