Gore Improves Data Architecture and Operational Efficiency Across Clinical

In order to accomplish a commitment to data-driven decision making and having a single platform across clinical, W. L. Gore & Associates’ medical business (Gore) recently conducted an enterprise-wide clinical transformation. Despite adopting Veeva eTMF in 2021, they were still utilizing their legacy CTMS system and had four separate EDC vendors.

Faced with decommissioning their legacy CTMS, Gore transitioned over 270,000 records and 27 unique objects across 35 studies to Veeva CTMS. Rather than migrating the unoptimized system to another hosting platform, they capitalized on a 12-month window to implement Veeva CTMS as part of their commitment to a single platform.

Kaylin Miller, clinical systems team leader at Gore, shared key highlights from their data migration and implementation strategy that helped eliminate operational siloes, improve data architecture, and cut data entry redundancy, while laying the foundation to support future innovations like AI.

Preparing for data migration

Gore initiated critical inventory assessments and deep dives into the legacy CTMS data structure prior to contract executions. This allowed them to clearly scope the project and build in additional resourcing to avoid slowdowns during the process.

“Discovery and strategy started well before implementation. Conducting a critical assessment of our data, the Veeva CTMS data model, and the overall scope of the migration helped us clearly define resource requirements and maintain business continuity throughout the project,” said Miller. This approach enabled them to take a critical lens to the data mapping process and be selective in determining essential data for the migration.

When they kicked off their first implementation workshops, their clear data standards and design choices expedited decision-making during migration and configuration. By June, the project team had their first migration workshop and locked configuration. To maintain agility and speed under tight deadlines they created three specialized workstreams: migration, validation, and process and training.

“Conducting a critical assessment of our data, the Veeva CTMS data model, and the overall scope of the migration helped us clearly define resource requirements and maintain business continuity throughout the project.” Kaylin Miller, Clinical Systems Team Leader, Gore

Technical execution and validation

With the strategic pre-work, complete data ownership, and established workstreams with dedicated subject matter experts, they were able to manage the data migration and implementation in parallel.

In order to foster autonomy and agility, Miller said, “we created a simple risk-based decision making model. Workstream champions were empowered to handle low and medium risk items on their own; high risk items were escalated to leadership with a strict timeframe for resolution.” This isolated focus ensured that data was prepared for migration without slowing down system configuration.

To ensure minimal errors during the validation phase, Gore established an iterative QC loop in their sandbox environment. The goal was to validate the migration process and loader sheets rather than a live data extract. Miller said, “Repeatedly importing the same data helped us identify errors and tie them to specific issues, highlighting exactly where we needed to clean data, update transformation rules, or adjust mappings.”

This upfront diligence meant that by the time they reached official validation, technical anomalies had been resolved. During their business go-live, they had zero errors and only two days of system downtime. Because end-users were already accustomed to the intuitive Veeva interface through eTMF, training and user adoption accelerated smoothly.

Business value realization and governance success

Gore ensured that the project team had subject matter experts from different business units involved in the implementation. By including a diverse group of subject matter experts, they were able to establish clear ownership and foster quicker decision making throughout validation and go-live. Miller said, “We made a point to align the skillsets, associated interests, and business needs of all of our project members assigned to the team. In doing so, the entire business understood the importance of the project and we were able to allocate additional resources when we needed extra support.”

The ultimate measure of Gore’s migration to Veeva CTMS was not just technical completion, but the governance model that made it possible and the improved efficiencies from being on a single platform. By shifting away from administrative legacy platforms to a modern unified platform, Gore improved how clinical operations functions globally.

The value of this implementation has also scaled beyond the clinical department. Recognizing that multiple divisions across Gore were adopting various Veeva applications, a cross-functional “Gore Veeva Community” was established. Meeting monthly across dedicated administrative and validation sub-communities, teams now formally share lessons learned, system architecture advice, and the exact data migration methodology that made the CTMS project successful.

Key Learnings

Throughout the 12-month migration and implementation process, Gore identified three key areas of success:

Start the process early – Establishing data standards, governance models, and prioritizing critical data requirements prior to migrating and implementing ensured accuracy and timeliness.

Strong team of subject matter experts – Providing project team members with autonomy to own workstreams resulted in effective and timely decision-making with high levels of accountability.

Adhere to a timeline with adequate resourcing – Resource requirements can shift throughout a project – having buy-in from leadership and allocating additional resources helped ensure ongoing support throughout the project.

Clean data governance and operational efficiencies are the foundational baseline required to unlock predictive analytics and AI-driven operational models in modern clinical development. Gore plans to build upon the single platform approach by adopting additional digital solutions and AI tools to support future innovation.

Learn more about Gore’s initial decision to adopt Veeva eTMF and CTMS.