Data-driven country and site selection is evolving from a tactical study-level activity into a strategic driver of global clinical development. As organizations face increasing pressure to deliver trials faster, smarter, and more efficiently, country and site decisions must balance immediate study needs with long-term portfolio objectives. Join us to explore how leading organizations are leveraging data, analytics, and enterprise thinking to optimize country and site selection through evidence-based decision making, align study placement with broader portfolio and network strategies, and strengthen site relationships through intentional partnerships.

Clinical trial sites are no longer a one-size-fits-all model. Independent sites, academic medical centers, health systems, site networks, community-based practices, and other emerging models each bring different capabilities, patient populations, infrastructure, and operational considerations. This session explores how understanding these site archetypes can inform a more intentional approach to feasibility and site selection. Attendees will learn how sponsors can look beyond traditional performance metrics to better match site characteristics with study needs, patient populations, and protocol complexity—building a more fit-for-purpose site strategy from the outset.

Strategic site selection, continuous site feedback, and tailored patient support accelerated enrollment in a clinical trial focused on Black/Latino participants. By prioritizing sites with strong community connections and incorporating operational insights, enrollment barriers were rapidly identified and addressed. Patient-centered resources improved access and participation, resulting in enrollment that outperformed expectations. This success demonstrated the value of intentional inclusion, positioning equity as a recruitment strategy and advancing more representative clinical research.

VA clinical research sites represent an extraordinary and underutilized resource for clinical trials, yet sponsors, CROs, and vendors struggle to engage them effectively. In partnership with NAVREF, SCRS conducted a first-of-its-kind survey of VA sites to surface the most persistent friction points across site-industry relationships. This session presents findings from that research and introduces the SCRS/NAVREF VA Site Playbook, designed to help industry partners work smarter with VA sites.

Clinical development has long treated protocol design and study feasibility as sequential activities, creating costly gaps between scientific ambition and operational reality. This session explores a new model: a connected planning ecosystem where patient, site, country, resource, supply, cost, and timeline considerations inform design decisions from the start. Learn how integrating trial design and delivery planning can improve predictability, reduce downstream surprises, and increase confidence in successful study execution.

Enrollment forecasting is a foundational but under-specified problem in clinical trial design, typically addressed through proprietary, closed-form tools that offer little insight into their underlying assumptions. Trial Planner, developed at Regeneron, formalizes enrollment projection as a discrete-event simulation governed by a hierarchical Gamma-Poisson process, embedded within an outer Monte Carlo framework to propagate parameter uncertainty. All parameters are estimated via Empirical Bayes, drawing on multi-source real-world data including operational trial history, EHR-derived prevalence, and competitor-trial activity. Preliminary evaluation demonstrates improved predictive accuracy relative to an established comparator method, with forecast calibration improving further as on-trial enrollment data accrue.

STRIDE (Site TRial Intelligence & Decision Engine) is Merck's AI-enabled platform that unifies site, investigator, and trial intelligence into a single decision-support workspace. This session shares how Merck transformed fragmented feasibility and site-selection activities into a transparent, human-centered AI workflow, integrating predictive analytics, recommendations, and structured decision rationale. Attendees will learn why data harmonization and model explainability are foundational to successful adoption of AI in clinical operations.

Partnerships & trial optimization and digital & technology partnered to implement an AI-enabled site feasibility survey platform. Built on Appian and integrated with an ecosystem of site, investigator, and country intelligence, the solution transformed site and investigator selection from a survey exercise into an intelligence-driven decision engine. It reduces site burden, improves response rates, streamlines workflows, and establishes a foundation for future AI-enabled study planning and site identification.

At Bristol Myers Squibb, we are reimagining feasibility and site engagement through an integrated AI-enabled ecosystem that connects trial planning, feasibility, site activation, and site execution into a seamless experience. Attendees will learn how AI-powered feasibility and enrollment forecasting can improve site selection, how AI can be leveraged to streamline manual activities like document exchange and clinical order set generation, and how digital access solutions create a unified site experience. The session will also highlight emerging capabilities such as intelligent questionnaires, predictive activation readiness, connected AI-generated insights, and proactive support that help sites succeed from study startup through execution.

Study start-up timelines have been increasing at a rapid rate. This session looks at underlying factors contributing to longer start-up durations and presents new data characterizing the inefficient process translating clinical trial protocols and related information into template source documents, study plans, and support materials. Implications of the results and opportunities and solutions to improve start-up efficiency, speed, and quality will be discussed.

This session will share Mayo Clinic’s approach to reimagining clinical trial start-up through agentically assisted site workflows. The presentation will highlight how protocol and study document data can be ingested once, routed downstream, and used to trigger timely operational reviews, reducing redundant data entry and handoffs while keeping human expertise focused on critical decisions that improve speed, consistency, compliance, and scalability, ultimately bringing cures to patients faster.

Roughly 37% of clinical trial sites under-enroll study volunteers, and 80% of trials fail to meet enrollment targets on time. Burden falls on both ends of the partnership – sponsors navigating unfamiliar site profiles and sites navigating difficult-to-reach sponsor requirements. This session walks through the site engagement lifecycle phase by phase, spotlighting field-tested toolkits and templates already reducing burden at each step, alongside the tools still missing that sponsors and sites are best positioned to build next.

Emerging sites represent one of the most promising—and most misunderstood—opportunities in clinical research today. They offer access to diverse patient populations, untapped geographic reach, and motivated teams ready to grow. This session equips sponsors and CROs with practical strategies to identify, evaluate, and effectively support emerging sites—transforming hesitation into confident partnership and expanding the research ecosystem in the process.