Rethinking Site Activation to Cut Startup Timelines

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 shows 55% of sites face over five months from selection to activation. What operational strategies could shorten these timelines?

Mallon: The survey does highlight that principally prolonged contract and budget negotiations are probably the top barriers to site activation, with about 66% of sites experiencing frequent delays.

To really shorten those timelines, I think we, at an industry level—sponsors and CROs—should, as far as is reasonably possible, try and prioritize standardization of clinical trial agreements, a degree of proactivity vis-à-vis budget alignment and negotiation, and certainly automation of or elimination of repetitive administrative tasks.

For example, at ICON, where we’re investing pretty substantially in certain AI-powered tools like Smart Draft, we can streamline contract negotiation by learning from historical negotiations and reducing cycle times up to 50%. Additionally, we see that centralization of site networks and pre-agreed master clinical trial agreements can certainly help simplify and accelerate approvals further.

Ultimately, treating contracts and budgeting as strategic enablers rather than administrative hurdles is key to faster activation. I would call out particularly that site contracting and budget negotiation typically remains an area where further improvement is needed.

On a call quite recently with the general counsel of one of our major customers, that point was made right back to us: “I’ve never seen any of these clinical trial agreements litigated, so we need to be a little bit more flexible.” That flexibility certainly helps, and we see that internally on the ICON side helping to improve site activation cycle times. We do see year-over-year improvement in that regard.