�Թϱ���

Terumo Corporation, a global leader in medical care solutions, cardiac and vascular interventions, and blood and cell therapy technologies, operates a global network with major hubs in the United States, Europe, and Japan, and delivers medical devices to more than 160 countries and regions worldwide.

Historically, Terumo’s clinical organizations managed clinical trials independently with different systems and processes. The teams relied on manual, paper-based processes and lacked the infrastructure for cross-regional collaboration. This resulted in fragmented systems and challenges when collaborating across multiple entities.

Against this backdrop, Terumo embarked on an organization-wide initiative to establish global alignment and autonomy with the goal of dismantling regional barriers, connecting global entities on a single platform, and establishing universal processes.

A group of global clinical leaders from different entities came together to discuss the evolution of the global clinical transformation initiative. Irene Barriocanal (Belgium), Takumi Ohira (Japan), and Michelle Wetherby (United States) shared insights on implementing a unified platform, autonomy and alignment at scale, and how the different entities collaborate to drive organizational change.

Achieving global alignment through a phased approach

To strengthen alignment across entities while maintaining local autonomy, the leadership team took a phased approach based on high priority needs across regions to ensure an effective roll-out.

Barriocanal, clinical study support systems lead, said, “We were not ready for a big-bang. We needed to start with the fundamentals, address our most pressing needs, and allow our people to learn the systems as they are introduced. Initially, our biggest priorities were documentation standards, audit-readiness, validation systems, and compliance monitoring.” As a result, Terumo moved forward with �Թϱ��� eTMF and CTMS to establish a foundation and begin understanding how end-users were adopting and utilizing the systems.

Ohira, clinical operations and clinical affairs member, said, “Prior to implementing �Թϱ���, we had challenges collecting documents from other entities due to different requirements. This made it difficult when submitting to the Pharmaceuticals and Medical Devices Agency (PMDA) – Japan’s competent authority.” Faced with distinct geographic requirements, governing bodies, and operating models, it was important for Terumo to establish alignment, while also allowing for autonomy to address the unique challenges each entity faced. He added, “Within �Թϱ��� Clinical we have standardized folder structure within our TMF reference model. This ensures we adhere to local requirements when using clinical data from other Terumo entities for Japanese submissions.”

Maintaining autonomy while achieving alignment

While the overarching goal of the transformation was to achieve alignment and standardization, Terumo emphasized the importance of understanding differing geographic requirements.

Wetherby, director of clinical research, said “When we do not have consensus, we leave our biases at the door and allow other entities to articulate why a certain system or process is important to them. We are seeing this with Site Connect – which is filling a massive gap in the U.S. due to the number of sites we manage.” Allowing different entities within Terumo to introduce new systems and processes for their needs allows them to set a standard that other entities can follow when the time is right.

Wetherby added, “Our entities are different sizes, the scope of our studies is different, and the challenges are different. It is important for us to navigate the breadth and depth of the businesses to maintain flexibility at scale.” Terumo Neuro led the effort to implement Site Connect due to the immediate need, but their European counterparts are now also benefiting from having the system in place.

By maintaining local autonomy within a single shared Vault, Terumo’s individual entities can independently pilot systems and develop best practices that are later scaled globally.

Achieving operational excellence on a global scale

Throughout the technology transformation, Terumo developed a comprehensive communication, education, and training strategy. Technology was viewed explicitly as an enabler to eliminate manual labor, but the focus was always on improving day-to-day operations for the clinical research and operations teams.

They approached education and training with the mentality that there needed to be a centralized standard that could be easily adjusted for different entities. Barriocanal said, “we had a multi-layered approach, including common training materials, change agents, and super users within each entity. This created a common education model, but also ensured that each entity was represented in developing the change management strategy while being able to tailor materials to the subjectivity of each entity.”

This baseline reinforced global alignment, but also enabled super users to further develop expertise within the system. Wetherby added, “As we have moved further away from implementation, our super users have established a strong foundation to disseminate information and make sure that our team is using the system to its full capabilities.” This allows other teams to follow on the same path with more efficiency and confidence in the process.

The impact of a unified clinical platform

Terumo Neuro was the first entity to utilize the full �Թϱ��� Clinical Platform and served as the proof-of-concept for the unified connection of eTMF, CTMS, and EDC. Wetherby was excited to understand how the systems would function together and help eliminate heavy IT requirements. She said, “By running entire studies end-to-end, we have improved capabilities for data visualization, tracking study status, and providing real-time updates with dashboards.”

With their connected clinical platform approach, Terumo Neuro achieved immediate results:

• Individual Monitoring Visit report compliance increased from 60–70% to over 85%
• On-time report completion raised to 85%
• Reports per study decreased from 140 to 30 on average

Successful implementation of technology, broad standardization of processes, and ongoing education have laid the foundation for future innovation and broader organizational success. Terumo Neuro’s implementation has provided valuable insights that can inform future initiatives across other Terumo entities.

Learn more about Terumo’s 3-phased organizational change management strategy.