The Makings of ‘Regulatory-Grade' Real-World Data in Ophthalmology Using AI

VH_WHITEPAPER_The Makings of Regulatory-Grade RWD_MAY2025_Page_1

Regulatory bodies, such as the Food and Drug Administration and the European Medicines Agency, are prioritizing real-world data (RWD) in clinical research and regulatory decision-making due to its potential to enhance drug development and improve patient outcomes.

Request your copy of this white paper to learn:

• The importance of artificial intelligence in transforming raw RWD into regulatory-grade evidence

• Key factors for ensuring the reliability and relevance of RWD when used in regulatory submissions

• How regulatory-grade data is being used in ophthalmology

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