Drug discovery is booming but the clinical-trial system is failing. Whilst data, technology, and AI tooling transforms other complex, safety-focused, and highly regulated industries (from banking to aviation), clinical trials are stuck with digital replicas of analogue processes. The fusion of smart design and intelligent technology offers solutions across the trial lifespan from data-led design, through operational planning and execution, quality management and medical oversight, to analysis and reporting. Previous trials will be used to demonstrate the opportunity for a new era of clinical-trial speed, cost, quality, and predictability in a variety of late-phase development settings.

As clinical development continues to evolve, mid-sized biopharma companies face increasing pressure to accelerate trial delivery while operating with lean internal teams and relying on outsourced execution through CRO partners. In this environment, providing oversight is not enough. We must transform how decisions are made throughout study planning and execution. 

This session explores the evolution of the study optimization in an organization that connects feasibility, country and site strategy, patient recruitment, trial diversity and functional excellence. Attendees will learn how one mid-sized biopharma is re-designing its operating model to strengthen internal capabilities, improve governance, and create greater consistency in study planning without increasing operational complexity. 

The presentation will share practical approaches to embedding functional excellence into Global Clinical Operations, modernizing country and site distribution strategies through technology-enabled planning, strengthening oversight in a fully outsourced model, and fostering a culture that focuses on data, cross-functional collaboration, and continuous improvement. Real-world examples will illustrate how organizational design, process optimization, and strategic use of data can drive more informed decisions during trial planning.

Most trials fall behind because eligible patients never learn research exists. Walgreens is changing that by using national patient reach and relationships to identify, reach, and activate potential research participants. This session covers what that model has delivered, where it works, and what it takes to operationalize at scale.

To build a highly efficient, audit-ready electronic Clinical Outcome Assessments (eCOA) ecosystem, clinical teams must integrate clinical operational needs with technical software architectures. Pfizer has consolidated the best practices across the six core pillars of a comprehensive eCOA strategy including patient centric solution design; project management & operations; reporting, analytics & quality monitoring; software build cycle time optimization; data management & statistical lock; and vendor management & governance.