Unlocking the Value of AI in IRT: Practical Perspectives from Vendors

Unlocking the Value of AI in IRT: Practical Perspectives from Vendors

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A Collaborative Vision from Moderna and Endpoint Clinical

Carrie Crawford, Vice President, Study Delivery, Endpoint Clinical

Brett Castano, Director, Clinical Supply Systems, Moderna

October 2025

Introduction: The Power of Partnership in AI-Driven Clinical Trials

In today’s rapidly evolving clinical research landscape, artificial intelligence (AI) is transforming how sponsors and vendors collaborate to drive efficiency, compliance, and patient-centricity. Moderna and Endpoint Clinical, leaders in clinical supply systems and study delivery, discussed practical, impactful applications of AI in Interactive Response Technology (IRT) and beyond.

Making AI Practical: From Vendor Conversations to Real-World Impact

Clinical trial teams are increasingly asking:

• “Can AI summarize requirements documentation to save time?”
• “Can AI generate test cases for user acceptance testing?”

These questions reflect a growing desire for AI to simplify complex, repetitive tasks—freeing experts to focus on what matters most.

AI as a Quality Multiplier: Oversight, Compliance, and Early Signal Detection

AI excels at narrow, repeatable checks that are critical for sponsor oversight and regulatory compliance. By automating anomaly detection, monitoring data completeness, and enhancing security hygiene, AI empowers sponsors to see earlier and mitigate risks sooner.

Key compliance signals include:

• Audit trail anomaly detection
• Data integrity after changes
• Security hygiene monitoring
• Pre/post-deployment comparisons

These capabilities align with ICH E6 R3 requirements, demonstrating robust oversight and control.

Natural Language, Smarter Data: Unlocking Insights Across Clinical Workflows

Imagine asking, “How many patients were randomized last week?” or “Did anyone change from an unblinded role to a blinded role in the study?” and receiving instant, actionable insights. AI agents now convert plain language queries into structured data analysis, enabling teams to drill down into patient events, site performance, and protocol changes with unprecedented speed and clarity.

AI-powered knowledge graphs connect data across patients, sites, and systems, revealing cause-and-effect relationships and helping teams answer “why” questions—such as the root cause of shipment delays or unexpected dosing changes.

Collaborative Data Storytelling: Visuals, Narrative, and Actionable Insights

Moderna and Endpoint Clinical believe that effective data storytelling is key to driving change. By combining narrative, visuals, and data, AI helps teams explain, engage, and enlighten—turning raw information into grounded, actionable insights.

elo™: The AI Assistant Transforming Clinical Trial Operations

Endpoint Clinical’s elo™ is a seamless AI-powered assistant embedded in the RTSM platform, simplifying complex processes for both internal and external users.

elo™ acts as:

• A knowledge agent for learning and growth
• An insights agent for data visualization
• A design agent for protocol analysis
• An audit agent for rapid compliance review
• An experience agent for guiding system usage
• A monitoring agent for alerting on system health
• A service agent for support and trend analysis
• A product agent for engineering and delivery
• A supply agent for clinical supply management

elo™ leverages agentic architecture to automate workflows, deliver smarter insights, and maximize productivity across the clinical trial ecosystem.

Conclusion: Shaping the Future of Clinical Trials—Together

The collaboration between Moderna and Endpoint Clinical demonstrates how sponsors and vendors can harness AI to drive quality, compliance, and innovation in clinical trials. By focusing on practical needs, regulatory alignment, and seamless user experiences, we are paving the way for smarter, more agile clinical research.