AAPS National Biotechnology Conference 2025: AI’s Role in Clinical Study Site Evaluation

At the AAPS National Biotechnology Conference 2025 (AAPS Bio), which was held in Boston from May 4–7, 2025, Jerry Chapman, principal, Quality Data & Analytics for Redica Systems, delivered an oral presentation entitled “Using Artificial Intelligence to Evaluate Potential Clinical Study Sites.”

In an interview with BioPharm International® following that session, Chapman discussed the advantages and high points of attending a conference like AAPS Bio, but also went into detail about some of the key takeaways in his presentation, including the methodology that is needed to produce a site risk analysis, and how artificial intelligence (AI) can be useful in predicting future risk factors.

“For AI to be successful, it needs to be applied to a foundation of facts. You need to have data that has been cleaned and labeled and enriched and categorized and scored, and then you can put the AI layer on top of that,” Chapman says in the interview. “This work is critical for ensuring that the AI can perform the correct evaluations once we have that foundation of facts and that clean data; then, we use the AI to look for semantic matches, and matches, for example, that have resulted in further compliance actions—in other words, language used in FDA observations is ranked based on severity by comparison against similar language, for example, in FDA warning letters.”

Click the video above to watch the full interview.

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