11:55 AM

Sponsored by: From Automation to Autonomy: How Agentic AI is Transforming Clinical Trials

As clinical trials grow in complexity, the need for intelligent, adaptive systems has never been greater. Traditional automation focuses on task execution, but Agentic AI represents the next evolution with systems that not only perform tasks but can also plan, reason, and make autonomous decisions based on real-time data.

In this session, we will explore how Agentic AI is accelerating the shift from reactive to proactive data management, and next steps in this evolution including exploring reasoning models such as DeepSeek. We’ll share our perspective on how this paradigm shift is enabling us to build more infrastructure that is adaptive, cost effective and truly scalable. Join us to explore how Agentic AI is setting the stage for a more efficient, insight-driven future of clinical trials, and where AI in clinical development is heading next.

12:45 PM

Sponsored by: Beyond Automation: Agentic AI and the Future of Clinical Trial Design and Execution​

We are entering the era of agentic AI—systems capable not just of analysis, but autonomous reasoning and adaptive decision-making. This session examines how agentic AI can reshape trial design, site selection, patient recruitment, and monitoring. It explores real-world pilots and governance frameworks that ensure safety, transparency, and human oversight, while unlocking efficiency and innovation.​

3:55 PM

Sponsored by: Designing with Foresight: Turning Operational Data into Protocol Performance

What if we could validate study assumptions before the first site is activated? This discussion dives into how combining AI with operational datasets enables sponsors to evaluate design hypotheses, identify amendment risks early, and optimize trial execution. Hear from industry leaders on how data-driven insights are reshaping protocol development and improving decision-making across the clinical lifecycle.

4:20 PM

Sponsored by: AI as the Catalyst: Re-Imagining Clinical Trial Delivery

AI is increasing trial predictability and speed but cannot deliver transformative value if applied to legacy processes, roles, and incentives. The future of clinical research requires purpose-driven processes, integrated data and redefined roles.

5:10 PM

Sponsored by: From Insights to Outcomes: A Practical AI Playbook for Trial Teams 

AI’s real value in clinical research isn’t automation alone — it’s connection. By linking decisions across the trial lifecycle, AI helps teams move faster, reduce friction, and focus on patients. This session cuts through the hype to show how AI supports trial teams in practice: shaping protocols that won’t stall, validating cohort feasibility, informing country and site mix, and activating recruitment when eligibility appears. We’ll outline the principles that make AI trustworthy — data quality, context, and interpretability — and where human checkpoints remain essential. The takeaway is a pragmatic view of AI as connective tissue across the workflow, improving efficiency and decision-making without losing sight of the people at the center of research.

5:22 PM

Sponsored by: Who's Training on Your Trial?

Every time your team pastes trial data into ChatGPT, where does it actually go?

This session breaks down the hidden data flows behind AI tools in clinical research and asks why our industry's obsession with data integrity seems to stop at the AI layer. You'll leave with practical questions to ask your vendors.

8:00 AM

BREAFAST PRESENTATION OPTION #1:
Sponsored by: Reaching the Unreachable: Proven Strategies You Can Apply to Engage Underserved Populations in Global Clinical Trials

Underserved populations are often excluded from clinical trials, limiting engagement, scientific validity, and real-world relevance. Traditional strategies often rely on outdated assumptions and overlook patient realities. This session reveals proven, globally scalable strategies to engage these communities through real-world data (RWD), behavioral insights, and human-centered approaches—replacing guesswork with precision to accelerate inclusive trial enrollment and shorten study timelines.

8:00 AM

BREAKFAST PRESENTATION OPTION #2:
Sponsored by: From Elusive to Enrolled: A Case Study in Precision Recruitment 

As the pace of innovation accelerates, scientific breakthroughs bring new hope to patients. Effectively including and supporting underrepresented populations is critical for the success of clinical trials designed to benefit these communities. GCI Health’s experts will share their “secret sauce” for building meaningful engagement with niche communities along with a real-world example of its methodology in action through its work with the University of Florida’s traumatic brain injury trial.

9:50 AM

Sponsored by: Agentic Clinical Trials in the Era of Commoditized Intelligence: A Case Study of an Agentic AI Platform Implementation across Six Clinical Trial Functions

The commoditization of intelligence is inevitable. Organizations that strategically apply frameworks like Verifier’s Law and The Jagged Edge will thrive, transforming their business model from labor arbitrage to technology-enabled strategic partnership. This case study demonstrates that by automating the verifiable and empowering human oversight for the complex, CROs can reverse the effects of Eroom’s Law, achieve significant competitive differentiation, and create a future where human skills are amplified, not replaced. The key to success is not merely adopting AI but architecting a collaborative ecosystem where human and machine intelligence work in a state of productive asymmetry.

11:15 AM

Sponsored by: Engineering for Speed and Trust: AI Agents in Clinical Operations Data Pipelines

Rapid, effective, and high‑quality data infrastructure for clinical operations is a critical success factor in enabling teams to make data‑driven decisions faster. This session will highlight how we are implementing AI agents across the clinical operations data engineering pipeline to deliver trustworthy insights and empower high‑quality decisions and actions at lightning speed.

12:30 PM

Sponsored by: The Next Era of eCOA: How AI Can Power Efficient, Streamlined eCOA Implementation

With AI entering the landscape of clinical research, new opportunities are taking shape for transforming the eCOA experience for patients, sites, and sponsors. This session will share learnings from how AI is being leveraged today for smarter and more efficient end-to-end eCOA study builds, reducing the timeline to go-live, and the transformative possibilities on the horizon for technology-driven data capture.

8:00 AM

BREAKFAST PRESENTATION:
Sponsored by: From Burden to Breakthrough: Innovative Strategies for Site and Patient Support

This presentation explores strategies to strengthen clinical trial site capacity and improve patient engagement. It emphasizes delivering customized solutions through specialized roles that integrate with site teams, flexible resourcing, and operational support across key activities such as prescreening, recruitment, data entry, and remote study visits. Additionally, it highlights the importance of global scalability combined with local expertise, supported by an oversight structure that ensures consistency worldwide. The ultimate goal is to drive measurable improvements in site performance, operational efficiency, patient engagement, and retention, creating a more effective and patient-centric trial experience.

8:55 AM

Sponsored by: Design Once, Execute Everywhere: Leveraging AI and PwC’s Digital Trial Core Solution to Orchestrate Modern Trials 

The next wave of clinical trial acceleration will not come from isolated AI tools, but from an integrated, end-to-end approach. This session explains how a Digital Trial Core enables bidirectional data flow across planning, protocol design, and execution, with AI augmenting clinical operations teams. Learn how other sponsors reduce manual effort, minimize amendment impact, and accelerate study start-up using AI-ready, standardized trial data.

9:50 AM

Sponsored by: Harnessing Gen AI for Clinical Development

AI agents are moving from hype to reality in clinical development, but success requires far more than building a model. In this session, Faro’s CEO will share real examples of how multiple Top 5 and Top 10 biopharma companies have moved beyond pilots to deploy AI agents that automate complex scientific, operational and regulatory functions, structure scientific intent into operational data, and accelerate core development workflows. We will break down the transformation required across four critical dimensions: organizational change management, technical and data readiness, regulatory expectations for transparency and traceability, and the security and compliance foundations needed to operate safely in a regulated environment. Attendees will leave with a clear blueprint for responsibly implementing AI agents at scale and the lessons learned from teams that are already succeeding.

12:00 PM

Sponsored by: From Proven Results to Product Vision: Advancing Clinical Trial Data Exchange with IgniteData Archer 

Clinical trial data exchange has long limited the pace of innovation in research. This session explores how IgniteData Archer is redefining what’s possible, drawing on proven results from live trials at Memorial Sloan Kettering Cancer Center. Presented by Joe Langfellner, IgniteData’s Chief Product Officer, the talk connects real-world impact to a forward-looking product vision—explaining why Archer’s success led him to join IgniteData and how he and the team are shaping the future of clinical trial data exchange.