User acceptance testing (UAT) is a critical component in clinical development where technology is used to capture and process clinical data. The sponsor/CRO must ensure that their system meets both protocol requirements and applicable regulatory requirements before their clinical trial system is used by patients. These systems must be proven to be complete and accurate because all tools provided to patients must be flawless and engaging for patient retention as well as compliance.

Since UAT is the crucial final step before a clinical trial system goes live, there’s a lot riding on it. Although UAT itself usually lasts only a week or two, if problems are uncovered, these discoveries can add significantly to the overall project timeline because fixes must be made, and then another UAT round must be conducted. As there are typically several systems (as many as five to seven unique systems) deployed on a given clinical trial, this is a significant undertaking by the sponsor/CRO. 

Often each system is verified independently, so there is not a complete assessment of the overall efficiency of the end user experience. As a result, inconsistencies in data structures or integration may occur, resulting in study start delays, system changes during the study, and even protocol amendments. A system modification during the study has a roll-on effect of potentially needing to update documentation, training documentation, translations where needed, and additional testing efforts.

UAT, the Studion Way

At Studion, we understand these challenges deeply because of our expertise in both the technical and the regulatory compliance aspects of clinical trials. We know how to create the best custom digital experiences for these trials because we understand how these systems are used in the clinical setting, whether they’re tech- or compliance-related; this makes us ideal UAT partners.

As Studion’s Director of Software Quality Engineering Nikola Pogacar says,

“Our biggest advantage is having both the technical expertise and regulatory compliance expertise.

We are familiar with developing the systems and can run complex, in-depth tests, but we are also familiar with the regulatory side of things.” The advantage of this facility with technology and compliance is more than a time savings, and a potential cost savings, for organizations dealing with the challenges of preparing their clinical trial systems for patient use: it’s also having the transparency of what you’re getting with your tech solution alongside a rigorous attention to quality. Additionally, our expertise will improve the patient experience of these systems in the long run.

Since patients themselves aren’t involved as the “users” in UAT, Nikola’s team works closely with each organization and their test scenarios to run through whatever specifics are needed, from data exports to study portals and beyond. “When scenarios are written, we get all the study-specific and custom software tested to provide reassurance that the system is functioning as expected, according to the tech specifications but also from the study protocol side,” he says. 

Since we know that patient retention dips if systems are glitchy or difficult to work with, UAT provides reassurance that such issues won’t arise and cause higher dropout rates. Because the stakes are high, it’s worth spending the time to get UAT right upfront. Our goal, though, is bigger than simply getting it right: we also want to provide an engaging digital experience to drive patient engagement and increase efficiency in trial execution.

If your organization has ever worked with several systems for a single clinical trial, you know that the UAT phase is challenging: you not only have to test each system, but you may have to do it through different vendors, and then review all the results and make necessary changes to each system separately. 

What we propose is a more holistic approach.

Studion leverages best practices for a comprehensive yet compliant approach, considering the overall clinical trial objectives and workflows, ensuring less overhead and headache. “Studion has the capability to bridge both worlds, the technical and the life sciences, and provide that support as a single point of contact,” says Nikola. 

We design a bespoke approach to test the complete workflow across systems, allowing us to identify inconsistencies and errors earlier and all at once, making the process more efficient and ultimately improving the patient experience. The better your patient experience is, the better and more reliable the data you gather; and having solid data makes successfully getting your drug to market that much more likely.