11:55 AM

Sponsored by: Site and Patient Realities: New Data and What It Means for Technology’s Role

With the increasing complexity of clinical trials, we are seeing a heightened responsibility and burden placed on both patients and sites. In this session, we will share insights from the industry’s most critical stakeholders—patients and clinical sites—shared in the 2025 CISCRP Perceptions & Insights Study and captured from Suvoda’s Site Advisory Board. The consensus? There is a growing need for streamlining and flexibility. In an industry where technology can be overwhelming, we will discuss how unified solutions can bring patients and sites together—reducing workload, enabling greater visibility, and ultimately delivering a smoother clinical trial journey.

12:45 PM

Sponsored by: Unlocking Outcomes: Innovative Central Lab EDC Driving Site-to-Lab Digitalization, Engagement, and Data Integrity

Clinical trials are going digital—but site-to-lab workflows have lagged behind, creating delays, inefficiencies, and added burden. This session reveals how real-time electronic data capture (RT EDC) and e-Requisition are closing that gap and transforming trial delivery. Discover how leading organizations are achieving dramatic results: query rates cut from 20–25% to as low as 1%, resolution times reduced from a week to under two days, and thousands of visits processed seamlessly across global sites. Learn how these efficiencies accelerate timelines for sponsors, reduce administrative load for sites, improve patient care, and support sustainability goals.

3:55 PM

Sponsored by: The Scientific Risks of Commoditizing eCOA

As eCOA adoption grows, scalable off-the-shelf solutions risk eroding scientific rigor. In this presentation, IQVIA experts Lindsay Hughes and Melissa Mooney will explore how commoditization threatens eCOA’s foundational principles and how to preserve integrity. Topics explored include: The behavioral science roots of eCOA, the impact of rapid tech growth, risks of misaligned implementations, and strategies to bridge science and technology.

4:20 PM

Sponsored by: ET at Home: Light Years from the Clinic—Designing Decentralized Trials That Meet Patients Where They Are

Join us for a deep dive into the design and execution of a fully decentralized Phase 3 trial for Ulixacaltamide, an investigational therapy for essential tremor. This session will explore how Praxis Precision Medicines leveraged patient-centric solutions to support trial participation entirely from home. This case study illustrates how decentralized trial models can drive both operational efficiency and meaningful patient impact. The discussion will highlight trial-design considerations, engagement strategies, and operational learnings, with broader relevance for community-based approaches in neurology research.

4:45 PM

Sponsored by: Investing in Patients: The Impact on Trial Delivery and Outcomes 

As clinical trials grow more complex, patient experience is increasingly recognized as a critical driver of success — but still often treated as optional rather than essential. In this breakout session, mdgroup and PTC Therapeutics explore what changes when patient experience is approached as a deliberate strategic investment.

Drawing on real-world insights from a complex Huntington’s disease study, PTC leaders will share why they chose to prioritize patient support, how that decision influenced trial delivery, and the tangible impact on recruitment, retention, operational confidence, and outcomes. The discussion will also examine how patient-centricity is evolving across the industry, what separates intent from execution, and what “best-in-class” patient experience will look like in the next generation of clinical research.

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: Imaging without Friction: The Missing Link in Faster, More Accurate Trial Delivery

Clinical trial imaging is a main source of operational frustration - creating delays, deviations, and rework. Drawing on real-world data, this session examines key failure points in trial imaging and their measurable impact on trial outcomes. Patrick McNamara, COO of Yunu, discusses how standardization, real-time oversight, and earlier quality intervention have reduced repeat imaging, shortened cycle times, improved data accuracy, and accelerated trial delivery while reducing operational burden.

9:50 AM

Sponsored by: De-Risking Clinical Trials while Improving Speed, Control, and Confidence 

Sponsors depend on clinical trial sites for the data that determines the future of their assets, yet limited visibility and control over site operations creates systemic risk including delayed timelines, budget overruns, and enrollment underperformance. Technology has been the default solution but has failed to address the core issue: the operational firewall separating sponsors and CROs from sites. This session introduces a breakthrough operating model. By integrating expertise and support directly into site workflows, sponsors can de-risk trials, strengthen site partnerships, proactively resolve issues, and establish a feedback loop for true visibility and control. Join industry leaders as they share why this approach succeeds where traditional strategies fail, and what it means for the future of clinical trials.

11:15 AM

Sponsored by: Assessing Participant Motivation to Inform DCT Strategy

Are virtual visits easier to attend for participants? Does the ease of no travel to a site equate to higher enrollment rates? As decentralized study designs have evolved, our industry has developed innovative ways to conduct scales and consenting and study requirements remotely. But with the advancements in capabilities, is interest and willingness from potential participants keeping up? Elligo Health Research has conducted over 20 decentralized/hybrid studies across 10 therapeutic areas in the US. Understanding participant motivation and barriers to appropriately plan strategies for enrollment is critical in all studies, and even more so when recruitment is dependent on external community referrals. Learn how Elligo Health Research has devised Enrollment Evaluation Criteria and uses the objective rating to guide solutions and strategy development.

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.