“Margo” Gains Generic IRB Approval - A Milestone for AI in Clinical Trial Enrollment

At Trially, we’ve always believed that technology should ease the path to better medicine, not complicate it. This week, we reached a major step toward that goal: Margo, our agentic AI for clinical trial enrollment, has received generic Institutional Review Board (IRB) approval.

That might sound technical but the impact is simple and profound. It means sponsors and sites can now use Margo in their participant recruitment and engagement workflows. It’s a green light for more qualified patient enrollment with fewer handoffs, and broader access for patients who want to participate in research.

How We Got Here

At Trially, we spend a lot of time in the trenches with research sites — listening, observing, and learning where AI technology can make the biggest difference.

When we launched Trially Match, our HIPAA compliant AI matching and patient-identification solution, one insight stood out across nearly every study we ran:

Sites could identify hundreds of potentially eligible patients within their electronic medical records (EMRs)…but most of those patients were never contacted.

Why? Because the sites were overwhelmed.

Many lacked the clinical research coordinators, call center staff, or dedicated outreach time to follow up. Even with great data, the human capacity to engage those patients just wasn’t there.

That’s when we realized identification was only half the solution. Engagement was the missing link.

Our team worked hand-in-hand with a central IRB to ensure complete transparency around Margo’s design, data safeguards, and quality-assurance processes. We showed how Margo protects participant privacy, adheres to strict suicide prevention guidelines, provides audit trails, and keeps a “human in the loop” to escalate complex or sensitive cases to study coordinators in real time.

What It Means for Sites, Sponsors and CROs 

For sponsors and CROs, this approval means you can integrate Margo faster into ongoing or upcoming studies without wasting valuable time and resources. For sites, it means faster enrollment, and less administrative lift so you can spend more time on high-touch patient engagement. 

And for patients? It means faster access to the studies that could change their lives.

Margo’s generic IRB approval is a milestone, but it’s also a signal of what’s coming next: an era where intelligent agents help connect more patients to more trials, at breakthrough speed. 

Because when technology and ethics move together, everyone wins.

Learn more about Trially Connect here