Hearts before hardware: How one sponsor reduced data management costs by 40%

At a time when AI and machine learning are dominating the narrative in clinical research, the idea of veering outside that box to solve longstanding issues can seem quaint or unserious. Personally, I’m a little tired of the “AI can solve all our problems” discourse. AI absolutely has value to bring to the table in solving tech problems. But when it comes to people problems? I’m a big believer in the notion that ultimately people solve people problems. And if you don’t believe me, consider the story of our partners at X4 Pharmaceuticals and how they revolutionized their own approach to clinical data management, not with more tech, but with a purely human-centric approach.

Data management costs rose while satisfaction declined

X4 is a small (150-person) CRO specializing in drug therapies for people with rare diseases. It’s a field that naturally calls for significant time and cost investments in clinical trial research. But they had two major issues:

1. Over a three-year period, their costs were projected to continue climbing.
2. Their user satisfaction scores were struggling. Frankly, some were brutal.

In the above chart you’ll see that from 2022 to 2023 their costs were projected to go up by 43%, and then another 22% between 2024 and 2025. At the same time, their user satisfaction scores across nearly every category were worsening – from initial database build and project deliveries, to responsiveness and cost control. Worst of all was overall satisfaction, graded as in “severe decline” year over year.

Costs were going up by double digits, all while user satisfaction with the output of those investments was bad and getting worse. It was clear to the X4 team that if they continued on this path, their timelines would only see further delays. A change was needed.

Charting a human-centric path with Zelta

Data managers tend to approach process problems like these from a technical perspective. It’s an understandable impulse. But Matt Dame, X4’s Senior Director of Clinical Data Management, divined that this was a human-centric problem that required a human-centric solution – something that could incorporate the needed tech elements into a plan that put people first.

So that’s what Zelta did.

As X4 moved to bring their first study in-house, it was critical to achieve alignment between all the stakeholders: IT, clinical ops, quality, and more. Together, Matt and the Zelta team convened a two-day session that literally brought these stakeholders all into the same room to drill down on the basics: identifying each stakeholder’s needs, quantifying those needs, and bringing the group to a consensus on how to move through these issues. It was a human gap that needed to be bridged with human solutions. We ran the session with sticky notes. And after two days of talking it out, everyone got into a flow where we figured out not just where the bottlenecks were, but what people wanted – for example, a global library standard for day-to-day delivery – that hadn’t been executed on yet.

After the session, X4 and Zelta created a project roadmap that we delivered jointly that resulted in that library, converting the organization to risk-based testing, evaluating and updating procedures, and partnering with the different groups to accomplish several other clear project goals that came out of that session.

Annual data management costs fall by 40%, as satisfaction scores soar

This back-to-basics approach allowed X4, leveraging Zelta, to land on an end-to-end, organization wide realignment and new direction.

The results speak for themselves.

Rather than the double-digit uptick in costs that X4 was originally projecting, costs are now expected to remain flat over the next three years – tantamount to a 40% reduction from what was initially planned. At the same time, user satisfaction scores have shown tremendous improvement. By 2023, every category saw moderate to significant improvement. This year’s scores demonstrate how that improvement has either remained steady or gotten even better. From 2021 to 2022, overall satisfaction was rated as in severe decline; now, from 2023 to 2024, overall satisfaction has shot up to significant improvement, with the highest scores on the board.

This wasn’t because of a massive technology overhaul, or a complete reorg of the company, or an enormous investment in AI and other bleeding-edge tech. It was simply X4 and Zelta working together to get all the relevant stakeholders into the same room for a few days, getting buy-in, and putting everyone in a position to decide for themselves what they wanted to do.

Finding the right partners

X4’s story sounds deceptively easy. In some ways, it is: at the end of the day it’s just getting the right people to talk to each other and come to a consensus. But that’s also much easier said than done. If it was just a matter of aligning schedules for a two-day meeting between the heads of IT clinical ops, and quality everyone would be doing it. And technically, anyone can do it. But it requires the right partners to help set you up for success.

Zelta worked with X4 to set the tone and vision for this human-centric strategy: identifying the stakeholders to focus on, their respective organizational priorities, and the upstream and downstream impacts of those priorities. But by working together with people like Matt, who came to the table with a relaxed and humble attitude of simply wanting to find what worked best for everyone, we were able to lay down a cohesive path for finding consensus and landing on the best idea, regardless of what the idea was and whose it was. That strategy ultimately led X4 to an outcome of enablement and empowerment, risk-based testing, and library creation and use – all relatively “smaller” changes on their own that together helped build momentum for the bigger shifts in costs and satisfaction that we saw above.

At the end of the day, everyone wants the same thing: to do a good job and feel like you did something worthwhile, that you can be proud of, and that moves the needle in a positive way. Zelta helps sponsors and CROs to stick that landing: facilitating collaboration that leads to the best, most actionable ideas that ultimately lead to more control, more flexibility, and more positive outcomes for clinical trials.