Events > Integration of Real-World Data (RWD) & Real-World Evidence (RWE) in clinical trials
  November 20, 2025 Nov 2025

Integration of Real-World Data (RWD) & Real-World Evidence (RWE) in clinical trials

As of 2025, the FDA’s AI and Machine Learning in Medical Devices Program reports over 900 active submissions leveraging AI for clinical or regulatory evidence generation i.e., a 60% increase year over year. Still, few organizations have the data maturity or governance models to scale safely. This session explores where Gen AI is already proving value—and what scientific and operational guardrails leaders must build to turn innovation into sustainable advantage

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