Applying AI to Reduce Administrative Burden Without Losing the Human Touch

In a recent video interview with Applied Clinical Trials, Brian Mallon, Executive Vice President, Site and Patient Solutions at ICON, discussed why site activation timelines continue to lag across the industry and what operational changes could help reverse the trend. Drawing on findings from a recent global survey, Mallon outlined how prolonged contract and budget negotiations, communication gaps, and increasing protocol complexity are contributing to startup delays. He explained how greater standardization, earlier and more meaningful site engagement, and the thoughtful application of AI and automation—particularly to reduce administrative burden—can accelerate activation without adding complexity for sites. Mallon also emphasized the importance of maintaining momentum during startup, adopting more site-centric practices, and strengthening bi-directional communication to better support site staff while improving overall study efficiency.

The below interview transcript was lightly edited for clarity.

ACT: How can AI and other operational innovations be applied in practical ways to address persistent startup delays without adding complexity for sites?

Mallon: To preface this, I’d say that AI is all fine and well, but clinical research is, at its core, a profoundly human endeavor. There’s nothing more personal than the choices people make about their health, and the relationship between investigators and the patients they support and treat is absolutely central.

Any technical innovation—AI or operational—must be viewed through that lens. The primacy of the investigator and patient experience is sacrosanct. The key role for AI and automation is around practical solutions to persistent startup delays, particularly administrative ones, but it should always serve and empower the people at the heart of research.

When we think about where AI can help, it’s about reducing administrative burden. Tools like Smart Draft help streamline contract negotiations by resurfacing precedents previously agreed by sites. That reduces burden, but these innovations must be thought through carefully at a very practical level, especially in terms of the site experience.

For example, providing a previously signed version directly to the site—rather than requiring them to search for it—makes the process tangible and helpful. That confluence of reduced administrative burden and real-world usability ultimately makes the process more efficient and user-friendly, without compromising the human connections and critical clinical judgment that define our field.