Why Startup Timelines Are Worsening—and How to Reverse the Trend

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: The survey notes worsening startup timelines compared to two years ago. What factors are driving this trend, and how can the industry reverse it?

Mallon: There does appear to be a trend toward elongated site activation timelines. It’s likely driven by increased protocol complexity, narrowing eligibility criteria, intensified competition for qualified sites, and heavier operational burdens placed on sites.

To reverse this, the industry needs to embrace more flexibility and engage sites earlier and more meaningfully, particularly at the feasibility and site identification stage. Historically, we asked blunt questions—do you have X, do you have Y—but at ICON we’ve moved toward being more probative: what do you need, and what would help with your participation?

Anticipating challenges and adapting to site-level information as it emerges allows sponsors and CROs to better support site needs and preserve momentum. Momentum really matters in study startup. If it’s lost, apathy can creep in.

At ICON, we’re not seeing worsening year-over-year timelines; we’re seeing improvement. What’s interesting is the variability across customers, which highlights how operating model decisions and pathways directly impact momentum. Visibility, trajectory, and communication of that momentum are critical for site engagement.