This track explores end-to-end strategies for designing and executing high-quality, efficient, and globally scalable clinical trials. It brings together global voices such as regulators, industry, academia, and patients, offering cross-disciplinary perspectives and emphasizing global harmonization of effort to address the most urgent operational and delivery challenges in modern clinical trials. Sessions highlight operational excellence, project management frameworks, technology-enabled solutions, and inclusive approaches that improve trial delivery from start-up through close-out. Attendees will gain insights into best practices for optimizing trial execution, managing vendors and partners, and ensuring operational readiness for increasingly complex trial designs.
Themes:
- Decentralized and Hybrid Trial Models: Innovative frameworks for remote and on-site trial execution, leveraging lessons learned from digital health technology integration and site adaptability
- Complex Trial Designs: Operationalizing adaptive, seamless, and platform trial models that require operational readiness for rapid, real-time design shifts and execution, with emphasis on aligning protocol design with executional feasibility while meeting regulatory expectations
- Technology-Enabled Operations and Project Management: Leveraging digital tools, real-time monitoring, wearables, and EHR integration to enhance trial efficiency and quality while applying robust project management frameworks for governance, risk mitigation, vendor oversight, and stakeholder alignment to ensure predictable, high-quality trial delivery
- Modern Modalities in Trial Operations: Site and sponsor readiness, logistics, and execution strategies for advanced therapies (cell and gene, genetic profiling)
- Study Start-Up Acceleration: Overcoming feasibility, contracting, and regulatory alignment barriers to streamline the most delayed trial phase for faster activation and first-patient-in milestones
- Site Burden Reduction: Scalable operational improvements to reduce workload, improve data collection, and enhance site satisfaction
- Patient and Site Engagement in Protocol Design: Practical approaches to embedding patient and site input early in development to enhance feasibility, improve recruitment and retention, and demonstrate return on investment (ROI)
- Inclusive Clinical Trials: Real-world case studies demonstrating measurable impact on inclusive recruitment strategies, addressing social determinants of health, site-community dynamics, and operational KPIs beyond the U.S.
- Vendor and CRO Oversight: Strengthening partnerships and governance frameworks to ensure delivery quality across trials
- Global Harmonization in Trial Delivery: Aligning operational processes, site requirements, and patient engagement approaches across diverse regulatory and healthcare systems
Key Questions to be Addressed:
- How can sponsors design and execute trials that are flexible, technology-enabled, and operationally feasible in real time?
- What proven strategies reduce site burden and accelerate start-up while improving patient recruitment and retention globally?
- How can strong project management frameworks and vendor oversight drive quality, mitigate risks, and improve trial outcomes?
- What practical solutions have delivered measurable progress in inclusive and globally equitable clinical trials?
