ELLA™ Receives Independent IRB Exemption Determination, Setting a New Standard for Ethical AI in Clinical Research

NEW YORK–(BUSINESS WIRE)–#AI—SOGLIA, the Patient Experience Organization (PXO) redefining how people connect with clinical trials, today announced that ELLA, its emotionally intelligent AI health advocate built on the E1 orchestration platform, has received an independent Institutional Review Board (IRB) exemption determination under federal guidelines, affirming its ability to ethically support clinical research through informational outreach and participant prescreening.

Trial recruitment remains one of drug development’s costliest challenges. Legacy tools, fragmented vendors, and static chatbots no longer meet the demands of speed, scale, or patient trust.

ELLA was engineered as a voice-first, conversational agentic AI health advocate, that engages prospective participants in real-time, emotionally intelligent conversations helping individuals understand study opportunities, gauge eligibility, and move toward referral with clarity and confidence. Powered by HXT’s enterprise-grade E1 orchestration platform, ELLA delivers secure deployment, governed knowledge models, and protocol-level customization that integrates seamlessly with existing site and sponsor systems.

“This milestone isn’t just a regulatory validation, it’s proof that responsible innovation can redefine what’s possible in clinical research,” said Carlo P. Calcagni, RPh, Founder and CEO of SOGLIA. “Where others have plugged single gaps with AI point solutions, we stepped back and reimagined the entire recruitment ecosystem. ELLA, orchestrated by our E1 platform, treats recruitment as an end‑to‑end experience, aligning human emotion, site workflows, and sponsor needs from the first signal of interest through enrollment and beyond.”

ELLA provides secure deployment, governed knowledge models, and protocol‑level customization. E1 integrates seamlessly with site and sponsor systems to reduce manual burden and create a compliant bridge from interest to informed action.

By engaging participants earlier and more empathetically, ELLA enables sponsors and sites to:

• Turn casual inquiries into qualified, trial‑ready conversations
• Reduce low‑yield or unnecessary screenings
• Shorten time to enrollment
• Scale efficiently while maintaining ethical, compliant engagement

SOGLIA invites innovators to rethink recruitment with the PXO model, the E1 orchestration platform, and the emotionally intelligent power of ELLA. Because the next generation of clinical trials won’t just be faster, they’ll be profoundly more human.

About Entrada Ventures Group

Entrada Ventures Group is a Patient Experience Organization focused on building and scaling transformative healthcare experiences. As the parent organization of SOGLIA and HXT, they accelerate innovation at the intersection of technology, patient experience, and clinical operations.

Contacts

Media Contact
Bethanne Toci
Bethanne@thinkentrada.com
For more information: www.askella.health