ICH E6(R3) Sparks Urgency, But Real Change Has Barely Begun

The 2025 Veeva Clinical Operations Oversight Forum in Copenhagen brought together sponsors, CROs, and technology partners to examine one of the most pressing challenges facing clinical development today: how to meet the evolving expectations of ICH E6 R3 while operating in heavily outsourced environments. Over several sessions, panel discussions, and working groups, participants confronted a shared reality. Regulators now expect continuous, risk-based, and fully documented oversight. Yet, many sponsors rely on legacy operating models that limit data access, delay decision-making, and prevent full ownership of critical processes. Across the forum, UCB’s detailed walk-through of its operating model evolution became a central reference point. The company illustrated how a global sponsor can reclaim operational intelligence, rebuild internal capabilities, and create a multimodal framework that strengthens oversight while preserving the efficiencies of outsourcing. Throughout the day, sponsors, CROs, and technology experts repeatedly emphasized the same theme. Oversight is no longer a passive activity. It is an operational discipline that requires the right blend of people, processes, and platform, supported by real-time data and a documented chain of decisions that withstands inspection.

The Core Challenge: Data Ownership, Fragmented Processes, and Regulatory Pressure

Discussions opened with a grounding question. Suppose R3 requires sponsors to demonstrate continuous oversight, complete data lineage, and documented risk-based decisions. How can this be achieved when the operational fabric of most studies sits with external partners? Sponsors highlighted scenario after scenario where the limitations of outsourced models became clear. CRO controlled CTMS platforms restricted visibility. Essential documents were spread across emails, Excel trackers, and meeting minutes that lacked an audit-ready structure. Data signals arrived too late to support timely corrective action. And amendments, often exceeding ten per study, created competence gaps when CRO teams changed and training records lagged behind the pace of protocol updates.

Multiple survey exercises during the forum showed that most sponsors remain in the early stages of R3 readiness. Many organizations are reviewing guidance and drafting action plans, but very few have implemented comprehensive changes. The most common challenges cited included adapting SOPs, integrating R3 into governance, establishing consistent quality tolerance limits, aligning with CROs on notification timelines, and finding a technology framework that supports oversight without adding administrative burden. Participants also indicated that many CROs still operate with department-specific oversight practices that are inconsistent, difficult to integrate, and misaligned with sponsor-level responsibilities. Several sponsors noted that CRO staff often lacked familiarity with R3 expectations, particularly around timely escalation, cross-system validation, and traceable decision-making.

UCB’s Multimodal Operating Model: A Data-Driven Rebuild of Sponsor Capability

UCB’s presentation provided a comprehensive, six-model view of how one sponsor rebuilt its operating structure after years of near full outsourcing. Leaders described how legacy strategies left the company with reduced institutional knowledge, limited data access, and a high inspection burden. One of the clearest examples came from a recent phase three program that spanned the United States, Europe, China, and Japan. When the pandemic halted recruitment and triggered rapid amendments, the sponsor found itself reconstructing oversight through fragmented trackers and delayed CRO updates. During inspection readiness, teams were forced to piece together historical decisions by reviewing years of spreadsheet logs and email chains, highlighting how little operational data had been retained in sponsor systems.

In the meantime, UCB developed a staged transformation that tested different operating models, reintroduced internal roles, rebuilt process maps, and adopted the Veeva Clinical Platform. Early models blended internal CPM (Clinical Project Manager) into CRO led studies, giving the sponsor some degree of high-level oversight while maintaining partner processes. Later models plan to bring CRO staff into UCB-owned CTMS environments, which will provide better data continuity but will require structured onboarding and role-specific training to ensure system competence. The largest step came with the creation of the new iHome model, an internal site engagement and study management framework supported by sponsor-controlled systems. Over time, iHome evolved through several iterations. The initial version relied on CRO platforms. Later versions leveraged Veeva CDMS and CTMS to consolidate operational data, improve real-time visibility, and streamline inspection readiness. In the newest version, UCB manages site-facing activities, operational decisions, and study execution internally, while selectively outsourcing specialized functions such as payments. Early site surveys showed striking results. Across several dozen participating sites, satisfaction averaged near the highest possible score, with investigators citing improved communication, faster issue resolution, and a more engaged sponsor presence.

Throughout these transitions, UCB emphasized that each model carries different benefits. Fully outsourced execution offers efficiency but reduces control. Hybrid models improve connectivity but require more governance. Internal models increase oversight and process consistency but are resource-intensive. The company now assigns models based on scientific and operational needs. Rare disease studies that require high site engagement typically fall under iHome, while large-scale programs with predictable workflows may operate under hybrid or outsourced models supported by sponsor systems.

A Broader Industry Movement: Aligning People, Processes, and Platforms for R3

In parallel sessions, sponsors discussed the broader industry implications of R3, highlighting that the regulatory shift is forcing a reassessment of long-standing outsourcing strategies. Several themes emerged repeatedly. First, continuous oversight requires continuous data. Sponsors must move away from end-of-month reporting and toward real-time access to operational signals. This requires unified platforms, structured metrics, and improved integration between CRO systems and sponsor systems. Second, governance frameworks must evolve. Sponsors noted gaps in escalation timelines, inconsistent expectations across partners, and SOP structures that treat oversight as an administrative task rather than an operational discipline. Third, change management is becoming a central determinant of success. Many organizations are updating SOPs, but few have built sustainable training frameworks that guarantee cross-functional competence across amendments, vendor transitions, and system updates.

Technology capability surfaced as one of the most urgent needs. Many sponsors still rely on spreadsheets because existing tools feel burdensome or incomplete. Forum participants repeatedly stated that oversight technology must be as simple as Excel but fully traceable, auditable, and integrated. In response, Veeva presented capabilities that support bidirectional CTMS data transfer, enabling sponsors to push back issues identified by sponsors to CROs, even when partners do not use the same platform. Presenters also highlighted ongoing industry collaborations, including a sponsor working group exploring how to adapt system functionality to R3 needs and how to create shared standards for essential records, QTLs, and inspection-ready documentation.

Future Outlook: Building Oversight Systems that Scale

Forum discussions made clear that preparing for ICH E6 R3 will require sponsors to rethink the foundations of their operating models. The most urgent step is early decision-making. Operating model selection must occur during the concept phase so that oversight strategy, system configuration, and CRO onboarding are aligned before a protocol is finalized. Participants also emphasized the need for defined oversight roles. Without dedicated responsibility, oversight becomes fragmented and inconsistent, prompting many sponsors to explore centralized frameworks or specialized oversight positions. SOPs will require deeper redesign as well. Instead of layering R3 requirements onto legacy processes, sponsors will need to embed oversight as a continuous, risk-based workflow that covers data flow, signal detection, decision-making, and documentation. Technology will play a structural role, providing audit-ready records, unified data lineage, and training environments that ensure functional competence across all contributors.

Yet the discussions at the forum revealed a gap between recognition and execution. While sponsors expressed strong alignment on the direction, most are still in early planning phases, updating documents and discussing models rather than implementing them at scale. UCB’s multimodal framework offered a rare example of operationalized redesign, demonstrating that meaningful change is possible without abandoning the efficiencies of outsourcing. For the broader industry, the path forward will require decisive action—investing in flexible models, modern governance, and data-driven oversight systems that allow every operational decision to be timely, traceable, and risk-based. Sponsors that move early will be better positioned to operate with confidence and regulatory readiness as R3 becomes the new operating baseline.