Terumo Medical Corporation Drives Clinical Excellence with Digital Transformation

Terumo Medical Corporation implemented the Veeva Clinical Platform through a 3-phase organizational change management approach, supported by Veeva Business Consulting for sustainable and measurable digital transformation.

I. Plan & Mobilize Change Strategy:

Terumo’s well-executed organizational change started with a vision and plan. The mobilization phase focused on understanding business goals, implementing right-sized change governance, and laying out a detailed plan.

Establish Change Rationale & Strategy

From the onset of the engagement, Terumo partnered with Veeva Business Consulting to map out a case for change and change strategy that addressed current state challenges, business goals, and mechanisms for change associated with the forthcoming transformation.

“We brought forward Veeva Clinical to shift to a more efficient way of managing clinical studies and engaging with global regulatory authorities.” – Sr. Manager, Clinical Data Management

Specific business goals associated with the transformation included:

1. Streamlined, technology-enabled clinical processes

2. Optimized engagement and interactions with regulatory authorities

3.Improved collaboration, visibility, and reporting

4.Enhanced compliance and inspection readiness

Once established, the case for change and change strategy served as a north star for Terumo’s leadership and impacted stakeholders, while reinforcing the business rationale for future work.

Gauge perspectives toward change and assess organizational readiness

Stakeholder input and engagement were top priorities for executive sponsorship, and Terumo conducted a series of stakeholder interviews to gain insights from impacted team members. These data points provided a critical line of sight into user challenges, awareness around the upcoming change, and visibility into areas of change resistance.

Partnering with Veeva Business Consulting to conduct stakeholder interviews allowed our leadership team to gather candid feedback and understand how to best support our personnel throughout the transformation with Veeva Clinical Platform.” – Sr.Manager, Clinical Data Management

This stakeholder analysis also enabled Terumo’s executive team to fine-tune change management priorities and proactively identify and mitigate pockets of resistance and other threats to successful transformation.

Design and implement robust change governance

By establishing the right governance structure, Terumo ensured partnership and input from the right functional leadership. They implemented a two-tiered governance model consisting of a steering committee (SteerCo) and change champion network.

SteerCo members provided functional input into the case for change, strategy, and roadmap and served as key decision makers for the change management process and future state. The change champion network consisted of influential clinical stakeholders at different levels in the organization, who worked with end users to drive adoption and compliance. The change champion network was optimally positioned between the SteerCo and end users to drive change objectives further into Terumo’s organization by ensuring accountability, providing support to end users, and reinforcing key messages, expectations, and process steps. The change champion network proved critical for ensuring SteerCo decisions translated into execution.

The change champion network included stakeholders at multiple levels of the clinical research and operations team, which allowed them to be highly effective at engaging with end users and solidifying the change movement” – Sr. Manager, Clinical Data Management

Implementing right-sized governance to shape, reinforce, and optimize Terumo’s future state was imperative for successful and sustained top-down change.

Develop comprehensive roadmap for change

Once Terumo established their business goals and specific needs, they worked with Veeva Business Consulting to create a comprehensive change project plan to capture the key effort areas and address items identified during the change impact analysis. The change roadmap served as a tool for mapping and managing the extensive list of activities and dependencies associated with the change effort. Additionally, the roadmap reinforced accountability across Terumo’s clinical research and operations team for change management activities like work instruction updates, communications, and training activities.

II. Process Optimization and Training:

As phase one of the change management engagement concluded, Terumo and the Veeva Business Consulting team shifted to enacting change. Phase two focused on execution of critical activities to align and prepare stakeholders and address pockets of resistance including process optimization, consistent and clear communication, and focused user onboarding to master core competencies.

Overhaul SOPs, work instructions, and workflows

Terumo’s next step for operationalizing change was to create clear documentation of future state business processes to set clear expectations and requirements for the team. SMEs worked closely with Veeva Business Consulting to understand how the introduction of the Veeva Vault Platform would impact day-to-day activities of the clinical research and operations team. The output of this exercise was 15 role-based workflows that mapped out how, when, and by whom would key decisions and activities be owned, managed, and executed in and outside of the Vault Platform. Terumo then aligned and packaged optimized workflows with existing SOPs and work instructions to ensure high-level business requirements were supported in the platform.

Plan and execute communications

Commitment to regular communication is fundamental to the success of any change management effort. To address this need, Terumo and Veeva Business Consulting developed a communications plan that outlined the detailed timing, cadence, channel, core messaging, audience, and owner of each event. This plan leveraged a variety of communication mechanisms including formal, highly planned leadership messaging like town halls and in-system demos as well as informal channels like emails and self-service reminders to reach audience members at different points in their journey. Veeva Business Consulting also helped to align these communications with Terumo’s future state processes and with Veeva Vault capabilities, resulting in streamlined transitions and greater preparedness.

Plan and execute training

Terumo and Veeva Business Consulting collaborated to efficiently upskill team members, outliningd a sequence of role-based learning objectives based on future state process and tools.

A tailored approach to training allowed our organization to maintain a focused and efficient pathway to end user competency and compliance while avoiding the pitfalls of blanket training.” – Sr. Manager, Clinical Data Management

Terumo leveraged custom training collateral including Veeva playbooks, quick reference guides, and in-system walkthroughs to address specific Veeva configuration and process requirements and put a Veeva toolkit in place for ongoing use.

III. Sustain and Optimize:

Change management is just the beginning of a successful business transformation, and to ensure success all stakeholders must work together to sustain, measure, and continuously improve the new operational paradigm.

Knowledge transfer

As phases one and two wrapped up, Veeva Business Consulting worked closely with Terumo to ensure change management activities extended beyond the initial engagement. This included a re-evaluation of roles and responsibilities for key change management activities such as training reinforcement, measurement, and continuous improvement. Additionally, they centralized critical change management collateral like governance documents, RACI matrices, communications, and training materials to ensure all required resources were readily available.

Measure change outcomes against business objectives

Terumo recognized that a fully-baked approach to measuring business transformation was critical to ensure accountability, communicate ROI, and identify continuous improvement opportunities. Veeva Business Consulting provided guidance and best practices while Terumo developed a KPI framework to align business objectives with Vault Platform data outputs. Additionally, Veeva Business Consulting ensured that the customer had the right technical knowledge to efficiently leverage platform data to answer critical strategic and operational questions at different levels of the organization.

Targeted continuous improvement

After successfully implementing and measuring performance against benchmark and/or target values, Terumo identified continuous improvement opportunities. Their change governance model provided an effective top-down framework for prioritizing, driving execution, and championing adoption of improvements on an ongoing basis.

A structured approach to change management allowed us to establish cornerstone processes, skills, and knowledge for how our organization would operate with the Veeva Vault Platform.” – Sr. Manager, Clinical Data Management

To speak to a member of the Veeva Business Consulting team about organizational change management, or similar offerings, contact us here business.consulting.comms@veeva.com