AI-Powered Clinical Research: From Compliance to Competitive Edge
Webinar Agenda
What We'll Cover in
60 Precise Minutes.
01 ——
The AI-Augmented Trial: Landscape & Opportunity
A crisp executive overview of where AI is delivering measurable ROI across Phase I–IV development — and the critical gaps most organizations are still leaving on the table. We'll map the current adoption curve and show where the competitive inflection point sits.
Phase I–IV AI ApplicationsROI BenchmarksAdoption Curve Analysis
02 ——
Regulatory Compliance in the Age of AI
ICH E6(R3), FDA AI/ML guidance, 21 CFR Part 11, and the EU AI Act — decoded for clinical operations leaders. We'll examine what these frameworks require in plain terms, where organizations are exposed, and the practical compliance architecture that protects your pipeline.
ICH E6(R3)FDA AI/ML GuidanceEU AI Act21 CFR Part 11
03 ——
eTMF Intelligence & AI-Powered Document Automation
How AI systems aligned to the DIA/CDISC TMF Reference Model v3.3 are transforming inspection readiness — reducing classification time by over 60% and flagging audit risks before inspectors do. Live demonstration of the Aurelyn eTMF Intelligence Engine workflow.
CDISC TMF v3.3Auto-ClassificationInspection ReadinessAudit Trail AI
04 ——
Building Your 90-Day AI Readiness Roadmap
A structured, actionable governance and implementation framework your organization can begin executing immediately. We cover change management, responsible AI policies, vendor evaluation criteria, and how to sequence AI adoption for maximum impact with minimum disruption.
90-Day FrameworkResponsible AI GovernanceChange Management
05 ——
Live Q&A with Sheilah Johnson-Rocha
Bring your most pressing questions. This session closes with an open, moderated Q&A. Attendees may also submit questions in advance upon registration. All registrants receive the session recording and a copy of the AI Readiness Assessment tool.
Live Q&ARecording IncludedAI Readiness Assessment