12:45 PM

Sponsored by: Bridging the Gap: Using AI and Real-World Evidence to Optimize Clinical Trial Protocols

As the integration of Real-World Data (RWD) accelerates across the industry, forward-thinking sponsors are moving beyond post-approval applications to utilize Real-World Evidence (RWE) at the earliest stages of clinical development. This presentation examines the evolution of RWE and its critical role in informing protocol development to create trials that are more efficient, patient-relevant, and aligned with market access requirements.

3:55 PM

Sponsored by: The Unified Digital Protocol: One Solution for Operational Planning, Cost Control, and Site Feasibility

The clinical protocol is a trial’s blueprint, yet its operational, financial, and logistical impacts are often assessed in silos leading to unpredictable enrollment, budget overruns, and reactive decisions. This session shows how to turn a static protocol into an agile asset by uniting activity-based modeling for budgeting and enrollment timelines with site-level feasibility data – enabling proactive risk mitigation and more predictable, smarter trials.

4:20 PM

Sponsored by: Reducing Trial Friction at Scale: Case Studies in AI-Native Automation

Clinical trial success depends on protocols designed around real-world patient and site needs and enabled by data and technology. In this session, CEO and Founder Dr. Amber Hill shares three case studies showing how AI-native automation improves feasibility, participant experience, and execution. Learn how early integration of automation supports patient-informed sourcing, site-friendly workflows, and scalable, participant-centric trial designs that improve recruitment, retention, and outcomes.

5:10 PM

Sponsored by: Design with Enrollment in Mind: The Feasibility‑Informed Protocol

Costly amendments and slow start-up often trace back to protocols that look sound on paper but fail in practice. This session introduces a feasibility-informed design loop that connects scientific intent to operational reality before protocols are finalized. We’ll show how teams define endpoints and eligibility criteria, then immediately stress-test those choices against cohort availability, geography, patient burden, and diversity targets. Through real examples, you’ll see how small adjustments can significantly reduce screen failures and cycle times. We’ll also cover how to operationalize this loop across clinical, feasibility, and operations using shared signals and documented trade-offs. The outcome is fewer amendments, faster start-up, and protocols built to enroll from day one.

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.

8:35 AM

Sponsored by: Accelerating Enrollment through Patient-Directed Strategies—A Global Phase IIb Tourette Syndrome Case Study (US, Spain & Germany)

With over 70% of randomizations remaining and only 5 months left of a 12-month enrollment window, a global Phase IIb Tourette study needed a new approach. In this session, you'll learn how patient-directed strategies across three countries increased average monthly randomizations by 255% and cut enrollment timelines by a year.

8:47 AM

Sponsored by: The Future of Global Patient Engagement: A Patient Experience Platform to Accelerate Clinical Trials through Creativity, Global Reach, Site Support Services, and Technology

Patient recruitment and engagement are major bottlenecks in clinical research. This session reveals how a Patient Experience Platform—integrating creative strategy, global reach, site/patient support, and advanced technology—transforms these challenges. Discover proven strategies to build trust, improve trial access, and retain patients. Learn how this approach leads to faster, more inclusive, and successful global clinical trials, with real-world examples.

9:50 AM

Sponsored by: From Parents to Participants: Precision Recruitment Strategies Powered by First-Party Data

In an age of increasing pharma skepticism, vaccine hesitancy, and fragmented rare disease care, how can sponsors succeed in enrolling the most complex audiences in clinical research? Drawing from new proprietary research, the team behind What to Expect and BabyCenter will share findings powered by an unmatched reach to 9 in 10 first-time pregnant women in the US and 36 million new and expecting parents globally each month.

This session will reveal key behavioral and attitudinal indicators of trial participation across critical segments. We’ll explore factors such as vaccine confidence, interest in specific content topics, and use of digital health tools that signal openness to clinical research. Discover how these deep audience insights grounded in first-party data translate into actionable strategies for successful recruitment and ultimately get life-changing therapies to families faster.

10:02 AM

Sponsored by: Designing for Real People: How a Pharma Company and Biorce are Using AI to Build Truly Patient-Centric Trials

Tired of hearing “patient-centric” with no real change? This session shows how a top pharma and Biorce are actually doing it, using AI to co-design trials with patients in mind. Think faster protocols, fewer burdens, real-world inclusivity, and documents people can understand. Join us to see what happens when empathy meets automation.

12:30 PM

Sponsored by: Designing Patient-First Digital Strategies to Accelerate Clinical Trials

Discover how patient-first digital strategies are reshaping clinical trial recruitment and retention. This session explores how AI-driven social listening and patient population science insights help identify and engage the most demographically and epidemiologically appropriate patients—faster and more effectively. Learn how precision pre-screeners, SMART screening and digital approaches reduce burden enhancing broader trial accessibility, improve retention, and enhance scientific validity and data quality, ultimately delivering more inclusive, efficient, and higher-quality clinical trials.

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.

9:00 AM

Sponsored by: AI & Innovation in Clinical Trial Financial Management

Join industry leaders to discover how innovation is transforming clinical trial financial management and accelerating site and patient success. Hear firsthand about the key features and tools they’re most excited to implement and get an insider’s look at early improvements, including streamlined payment automation and stronger site outcomes. Whether you’re exploring AI in clinical trial financial management or seeking ways to boost results for sites and patients, this session delivers forward-looking insights and practical lessons from the field.

9:50 AM

Sponsored by: Empirical Impact of Protocol Complexity on Enrollment Speed and Patient Withdrawal in Clinical Trials

We developed a multi-dimensional, quantitative framework to measure protocol complexity and applied it to digitized data from thousands of clinical trials conducted over the past decade. Using empirical models, we quantified how specific complexity dimensions influence enrollment speed and patient-initiated withdrawal. Scenario-based analyses demonstrate how targeted protocol simplification can improve operational performance and support more efficient prospective trial design.

12:00 PM

Sponsored by: Optimizing Clinical Trials: Leveraging Payer Insights and Real-World Data for Recruitment and Site Planning

In an industry where 85% of clinical trials fail to recruit or retain enough participants, precision targeting is crucial. This session explores how robust pharmacy and medical claims data – enhanced by payer insights – can be used to rapidly identify patient cohorts that match detailed study criteria and pinpoint where those patients reside. By leveraging real-world data and payer insights in study planning, sponsors can avoid protocol revisions and costly delays. Attendees will learn how a data-driven approach to clinical criteria and site selection ensures that only the most relevant patients enter the pipeline. Attendees will learn how data-driven clinical criteria and site selection ensures only the most relevant patients enter the pipeline, and they will understand how payer-informed targeting and outreach improves speed, scalability and overall trial performance.