As data management applications become more commonplace across the clinical sphere, and teams search for new ways to use technology to grow more agile and cost-effective, experts with deep knowledge of the people and process factors have emerged as a critical means to deliver value and mitigate risks associated with adopting new tools.
Achieving the best outcomes for a trial requires creating the right process environment that puts a premium on worker capability and knowledge, and where tools, processes, and people combine to execute requirements for specific processes.
That’s the approach X4 Pharmaceuticals took when they partnered with Zelta to conquer two challenges they were facing: rising data management costs and declining user satisfaction with how clinical studies were shaping up. From 2021 to 2022, X4 was seeing user satisfaction scores drop into the “worsening” or “severe decline” categories on a wide range of issues, reflected across cost control, speed of initial database and mid-study update deliveries, responsiveness, and overall satisfaction.
The cost front was especially thorny, with annual data management costs estimated to rise by over 40% in 2023 and another 22% in 2025. All of these concerns prompted a change – one that was facilitated by working with Zelta.
Zelta by Merative is a cloud-based eClinical solution that delivers enhanced data management for clinical trials, with human-centric advisory services provided to optimize performance. While Zelta possesses ample capabilities for automation and supervised machine learning, the company’s approach continues to emphasize the importance of human expertise.
This combination of clinical data management platform and a people-first process helps users build internal self-sufficiency rather than dependence. Zelta helped X4 develop a strategy for aligning internal stakeholders, like IT and clinical ops; identifying each team’s needs; and bridging a consensus between these needs. The result was a two-day discussion session that ultimately not only identified where the bottlenecks were, but also how to execute the solutions needed for breaking through – like a global library standard for day-to-day deliveries.
“We’ve had customers that have been with us for a decade-plus, and the process improvement portion is always available to them. But we enable them to run their own organizations,” says Erickson. “That philosophy really shines through when we’re designing processes and technical solutions to integrate with Zelta. We have to think differently because our clients won’t need us forever.”
The outcome of this strategy was a transformed organization that soon began seeing user satisfaction scores skyrocket across every issue area – up into the “improving” and “significant improvement” grades – while projections of data management costs fell by 40%.
These results were made possible by a human-centric approach that laid out clearly who needed to be involved, what their priorities were, and what the cross-organizational ripple effects of those priorities would be. These process improvements were driven by Zelta’s external guidance and in close collaboration with internal stakeholders – in other words, by people, not tech.
“Zelta enabled us to do everything we wanted to do,” said Matt Dame, Senior Director of Clinical Data Management, X4 Pharmaceuticals. “We’re a small company. Building databases ourselves is a huge endeavor. Zelta helped us shave hours off our migrations, and provided constant support that other vendors could not.”
“We want our clients to be in control of how they use the Zelta platform and so we do not set up services as a continuous revenue or cost drain, but instead we structure our services teams to deliver specific outcomes,” explains Kofi Darkoh, Vice President of Consulting Services and Customer Solutions at Zelta by Merative. “For example, when we think about training, we take a mentored approach, which means the content is never abstract; it’s directly tied to what the client needs.”
By providing a vision of a potential future and a strategy for how to get there, the right consultants can provide both the insights and support needed for sponsors and CROs to achieve their business ambitions, on their terms.
To learn more about how Zelta can help boost efficiencies, reduce risks, and deliver new value in your clinical trials, download the free report below.
