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Regulatory

Services

Positioning your TwinRCT for regulatory success

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Our team has deep expertise in navigating the dynamic regulatory landscape of AI-powered clinical research. From supporting your interactions with regulatory agencies to providing language for protocols and statistical analysis plans, we're here to empower your success every step of the way—while prioritizing transparency, reproducibility, and trust in our technology.

European Medicines Agency

In September 2022, the European Medicines Agency (EMA) qualified our PROCOVA^TM procedure, providing a regulatory framework for the application of TwinRCTs in Phase 2 and 3 clinical trials with continuous outcomes.

Read the EMA's qualification opinion

Blog

Our perspectives

View all

US FDA comments on Unlearn’s PROCOVA methodology
Date
January 2, 2024
Our Strategy for Navigating the Regulatory Landscape of AI in Drug Development
Date
May 30, 2023
Success is never a straight line—reflecting on our EMA draft qualification opinion
Date
March 31, 2022

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