AI in Clinical Trials
Evaluating AI Responsibly: What Trial Sponsors Need to Know
Free Webinar | Wednesday, April 8, 2026 | 11:00 AM — 12:30 PM ET | Live + On-Demand Access
Artificial intelligence is rapidly entering clinical trial operations, oversight, and compliance workflows. As organizations begin evaluating these technologies, many clinical teams are asking the same question:
What does compliance actually look like in the age of AI?
Recent principles from the FDA and EMA make clear that AI-enabled systems cannot be approached in the same way as traditional software. In regulated clinical environments, compliance now depends not only on functionality, but also on context of use, credibility, governance, human oversight, data stewardship, and lifecycle control.
This webinar is designed to help clinical professionals understand how AI is being applied in clinical trials and what responsible deployment should look like in regulated environments.
The goal is not to turn participants into AI experts. Instead, attendees will gain the foundational knowledge needed to:
- Understand how AI is entering clinical workflows
- Evaluate AI solutions more confidently
- Recognize what regulators expect when AI influences clinical operations
Page Sections
What to Expect
This 90-minute webinar is the first in a series on AI in Clinical Trials, designed to help sponsors move from curiosity to confident, responsible adoption.
The session centers on a deep dive into what compliance actually looks like in the age of AI, grounded in evolving FDA and EMA expectations.
It then moves into a panel of early adopters sharing what happens when AI enters real clinical environments — including how solutions are evaluated, where challenges emerge, and what early benefits are being realized.
What You'll Learn
- Why AI must be evaluated differently than traditional software
- How FDA and EMA expectations are reshaping AI oversight
- What “context of use” means in clinical workflows
- What to look for in governance, credibility, and validation
- How to distinguish meaningful AI from superficial use cases
Who Should Attend
This webinar is designed exclusively for trial sponsors responsible for:
- Clinical operations
- GCP compliance and quality
- TMF and trial documentation
- Clinical systems and innovation
- AI evaluation and implementation
Agenda - Wednesday, April 8
11:00 AM ET
INTRODUCTION
Where Trial Sponsors Are Today and Why This Matters Now
Aaron Grant, Head of Innovation, JUST IN TIME GCP
Kristen Hunter, Marketing Lead, JUST IN TIME GCP
- Review participant demographics, including experience levels and company size
- Understand how sponsors describe their organization’s current approach to AI
- Explore common barriers to evaluating and implementing AI
- Frame why asking the right questions about AI now matters for clinical oversight and compliance
11:05 AM ET
PRESENTATION
What it Means to Be Compliant in the AI Age: FDA and EMA Perspectives for Clinical Sponsors
Kathie Clark, Industry Expert; Technology & Innovation Partner, JUST IN TIME GCP
- Understand how FDA and EMA principles are reshaping expectations for AI in regulated environments
- Recognize why AI-enabled systems must be evaluated differently than traditional software tools
- Apply the concept of context of use when assessing AI within clinical workflows
- Identify what sponsors should look for in governance, credibility, validation, and data stewardship
- Distinguish meaningful workflow AI from superficial uses of large language models
- Understand what responsible AI deployment should look like in regulated clinical operations
11:35 AM ET
PANEL DISCUSSION
Lessons Learned from Early Adopters: From Curiosity to Implementation to Realized Benefits
Experts share firsthand experiences from organizations that have moved beyond curiosity and begun implementing AI within clinical trial operations and compliance workflows.
Moderator
Aaron Grant, Head of Innovation, JUST IN TIME GCP
Panelists
TBD
- What first sparked internal curiosity about AI within their organizations
- Barriers encountered during evaluation and implementation
- How organizations prepared their teams and culture for introducing AI
- Early operational benefits observed from AI-supported workflows
- Lessons learned for organizations beginning their AI journey
12:20 PM ET
LIVE AND UNFILTERED: SPEAKER Q&A SESSION
(Not Recorded—Must Attend Live)
Get face-to-face (virtually) with the previous speakers in an exclusive, live-only Q&A. This is your chance to ask the real questions—the ones you’ve been dying to ask but never see on a slide.
No slides. No recordings. No judgment. Just candid conversation, behind-the-scenes insights, and the space to dig into what really matters.
12:30 PM ET
WEBINAR ENDS — On-Demand Version Available for 30 Days
What Registration Includes
- Live participation in the 90-minute live webinar
- Includes expert presentation, moderated panel discussion, and live Q&A
- Insight from anonymized participant data showing how sponsors compare across confidence, experience, and approaches
- 30-day access to the on-demand recording (presentation and panel discussion; live Q&A excluded)
- Downloadable copy of the slides presented sent post webinar
- AI Vendor Evaluation Scorecard sent post-webinar
Complimentary Tool — AI Vendor Evaluation Scorecard
A structured, inspection-aligned scorecard to help trial sponsors evaluate AI vendors based on credibility, governance, transparency, and GCP alignment, not just functionality.
- Built from emerging FDA and EMA expectations for AI in regulated clinical environments
- Highlights where AI solutions can introduce risk across oversight, transparency, and data use
- Provides practical context to help sponsors evaluate credibility, governance, and fitness for purpose
- Designed to support internal discussions on responsible adoption and defensible decision-making
Sent following the webinar along with the presented slides.
