Siemens Healthineers and Vantive Transform Clinical Operations to Scale Globally

The medtech clinical trial landscape is transitioning to digital infrastructure to improve operational efficiency, regulatory compliance, and patient-centricity. Siemens Healthineers and Vantive are two medtech organizations that recognized how a digital clinical platform is the next step in scaling their teams.

Lynn Meyers, senior director of clinical operations at Siemens Healthineers, and Deborah Kasprowicz, global head of worldwide medical strategy and delivery at Vantive, highlight best practices, challenges and successes of their respective transitions from manual processes and disconnected systems to a unified, digital ecosystem.

IVD landscape complexity

Unlike medical device or pharmaceutical trials, in vitro diagnostics (IVD) studies often analyze samples rather than patients, creating a large volume of samples from many sites that can be difficult to manage without a unified system. This distinction changes every phase of trial execution including regulatory compliance, protocol design, and performance metrics.

Because IVD requires highly specialized testing, ignoring the unique requirements can create significant operational bottlenecks. Teams that rely on manual processes and siloed systems quickly succumb to these complexities, triggering inefficiencies like slower trial conduct, compliance risks, increased costs, and lack of oversight.

Harmonizing global operations at Siemens Healthineers

Siemens Healthineers’ digital transformation journey required addressing both operational infrastructure and organizational culture. Legacy infrastructure, which relied heavily on paper, manual workflows, and lacked active study management, no longer supported their robust clinical management needs as they took a more patient-centric approach to trials.

“We finally got to this point within the team where we realized we need modern systems to improve our delivery, to manage our risk, and to produce a quality product,” said Meyers. So the medtech shifted to focus on operational excellence by focusing on three critical components: people, process, and technology. In November 2025, Siemens Healthineers initiated their eTMF/CTMS project with support from Veeva Business Consulting. This partnership focused on cross-functional alignment, establishing industry best practices, and defining key success metrics ahead of project completion.

Vantive’s study continuity amid a spin-off

Vantive, on the other hand, faced an accelerated sprint for their clinical transformation. Following the spin-off from Baxter’s renal division into an independent vital organ therapies company, Kasprowicz’s team had to establish an entirely new clinical infrastructure while keeping their active study portfolio running seamlessly.

“Prior to Veeva, we didn’t always see real time data transfer like we would have liked. So when we thought about study status, there might have been a delay in enrollment numbers transferring over or other information that was only partially available to us,” said Kasprowicz.

This delay risks creating roadblocks in study timelines. For Vantive’s next platform, speed and efficiency were non-negotiable.

To navigate the transition, Vantive built a wish list for their ideal clinical platform, prioritizing:

• Deep connectivity: Eliminating copying and pasting from CTMS, and Excel-based tracking via robust integration between EDC and CTMS.
• Streamlined workflows: Allowing leaner teams to do more with less through intuitive, cross-trainable interfaces.
• Standardized reporting: Accessing real-time, out-of-the-box platform metrics rather than building manual dashboards outside the system.

Launching a new company while navigating the updates to ISO 14155, shifting to risk-based studies, and driving efficiency reinforced Vantive’s need for a unified digital platform.

Partnering with Veeva MedTech, Vantive executed an aggressive deployment strategy. Beginning in late 2025, the team successfully launched Veeva eTMF, Veeva CTMS, and Veeva Payments within months, before deploying the EDC to CTMS Connector in April 2026.

Instead of treating their clinical platform as a passive archive, Vantive now uses Veeva Clinical solutions to actively author, approve, and manage monitoring trip reports directly within the system drastically improving visibility and TMF completeness. “Our records management team will have better visibility to the study records and to the metadata, allowing them to close out studies more smoothly,” said Kasporwicz.

Lessons learned

Siemens Healthineers and Vantive’s experiences offer a practical blueprint for clinical data and operations professionals driving digital transformation. Meyers and Kasprowicz shared three key lessons learned for other medtechs looking to transform their clinical ecosystem.

1. Shift from archiving to active authoring: Modern platforms drive active workflows enabling real-time collaboration, visibility, and quality control from study startup to closeout.
2. Dedicate resources to enablement: Allocating dedicated internal subject matter experts to at least 50% to 100% of enablement activities reduces strain on the team and accelerates timelines.
3. Prepare for a risk-based, AI-driven future: As global regulatory standards (ISO14155, ISO20916) evolve, leaders must look toward advanced technologies. AI and risk-based data monitoring will redefine operational efficiency while enabling more time for human critical thinking.

For more insights on unifying clinical, read how other medtechs scale clinical trials with a unified platform.