Importance of DCTs Moving Forward

As adoption increases, regulatory bodies are becoming more involved in the oversight of artificial intelligence.

New amendment explicitly states that in vitro diagnostic products are devices under the Federal Food, Drug, and Cosmetic Act.

In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.

A representative sample patient population that accurately reflects the overall population is vital to establish the safety and efficacy of a drug.

Harnessing these tools for successful integration and streamlining of processes.

The current clinical development model is shifting toward a generative AI-augmented proactive approach supported by real-world data for real time evidence.