This session presents Dynamic Shared Ownership (DSO) as a disruptive operating model for Clinical Operations, replacing hierarchical, country‑based structures with empowered, skill‑based network teams. By shifting decision‑making to the point of execution and enabling dynamic cross‑border resource flow, Bayer achieved a 25% increase in productivity and efficiency, accelerated study timelines, and reduced management layers—while maintaining quality and delivery performance in a regulated clinical trial environment.

Shifting from transactional interactions to true partnership between Sponsors, CROs, and investigational sites is essential for successful portfolio delivery. Aligned engagement strategies, shared accountability, and clear roles help reduce site burden, improve study performance, and enhance the overall site experience, particularly in complex and rare disease settings. Drawing on practical examples, this session highlights approaches to strengthening long-term relationships, streamlining and harmonizing engagement activities, and thoughtfully expanding site networks. It will also explore how closer collaboration across partners can drive consistency, increase trust, and accelerate execution while enabling more sustainable ways of working.

Discussing the evolution of strategic site partnerships through advancing a model which integrates sponsors, sites, and scientific stakeholders earlier in development and across the full study lifecycle. By aligning scientific ambition, operational strategy, and site capabilities upfront, the model drives faster study start-up, improves execution predictability, and enables scalable, long-term engagement with priority research partners.

To understand key unmet needs of clinical trial sites through primary market research analyzed against hypotheticals, we will review different types of trial sites to further refine persona characteristics, drivers and behaviors, goals, pain points, expectations for sponsors, and key information sources. The goal is to develop a targeted engagement model curated for a respective trial site enhancing the collaboration, productivity and relationship.

Novo Nordisk reduced site-facing training burden by over 25% by creating a centralized Site Learning Unit and streamlining processes to deliver optimized learning. By eliminating unnecessary training, accelerating site startup, and strengthening site partnerships, we improved operational efficiency while maintaining ICH GCP E6 R3 compliance. Join us to explore the challenges, solutions, and lessons learned during this transformation.

Despite years of industry focus on digital innovation, clinical trial sites continue to struggle with the same technology burdens: fragmented systems, duplicated tasks, and workflows that don’t reflect how sites actually operate. Our research highlights a core issue behind these long-standing challenges: sponsors and vendors often design or choose technology without deeply understanding site realities. This session explores what we learned from extensive site engagement, why short-term fixes aren’t enough, and how truly impactful change requires rethinking our approach—starting with listening, mapping real workflows, and adapting technology to people, not the other way around.

This session explores how increasing scientific complexity, technology fragmentation, and operational pressures are creating unsustainable burdens for clinical research sites. It highlights the need to move beyond sponsor‑centric models toward true partnerships with research centres, focusing on site‑centric design, digital integration, and co‑developed solutions to enable more efficient and scalable clinical trials.

Study start-up timelines have increased significantly. This session examines underlying causes including new data on how sites translate clinical trial protocols and information into template source documents and study support material. Tufts CSDD, in collaboration with CRIO, gathered survey data from 209 global investigative sites. Systems and workflows that sites use to capture, manage and transmit data and challenges encountered will be discussed along with opportunities to improve start-up efficiency, speed and quality.

Based on insights gathered from Alzheimer’s disease trial sites, J&J established the AD Advisory Board within its Site Advisory Network to create a more structured, long-term partnership model with sites. Comprised of global investigators and KOLs, the Board is designed to identify operational bottlenecks, feasibility challenges, and opportunities for earlier collaboration across the clinical development portfolio. This session will highlight early learnings from the setup and launch of the initiative, including co-created priorities focused on reducing site burden, improving operational processes, and strengthening scientific partnership. Attendees will gain practical insights into designing scalable, collaborative site engagement models that support more effective trial execution.

Most organisations shifting to FSP change the contract but leave the operating model untouched—governance, resource classification, performance management, IT provisioning, and financial reporting still designed for full-service outsourcing. The result is structural friction between sponsor and CRO teams that no goodwill resolves, because the system itself is misaligned. This session examines the operational fault lines that emerge when sourcing strategy outpaces organisational readiness. Drawing from direct experience leading a multi-CRO FSP transformation across site management, study management, and clinical data functions, the speaker presents a practical framework for closing the gap—from both sponsor and CRO perspectives.

Africa conducts just 3% of global clinical trials despite a high and diverse disease burden. This session presents ACRN’s model for transforming fragmented sites into a federated, audit-ready network enabling scalable trial delivery across emerging markets. By integrating robust digital infrastructure, AI-enabled analytics, standardized operations, regulatory alignment, and community-centered recruitment, ACRN accelerates site readiness and improves participant access. The model offers a clear pathway to increasing Africa’s share of global trials to 15% while strengthening data quality, efficiency, and equity.