Overview
User Acceptance Testing (UAT) is a critical step in validating electronic clinical outcome assessment (eCOA) or electronic patient-reported outcome (ePRO) software before it’s deployed into live study environments. However, proper execution of UAT typically requires significant time and resource investments, along with the right skill sets, to streamline the end-to-end testing workflow.
Studion provides UAT as a managed service, providing timeline protection, scalable capacity, independent support, and documentation quality. With significant expertise conducting UAT for clinical trials, Studion helps eClinical technology providers or study sponsors speed up the timeline to first patient-in (FPI) milestones while meeting regulatory rigor, all without requiring additional internal resources.
Our Partner
Our partner, an eClinical tech company, engaged Studion for its deep eCOA/ePRO expertise, high-quality and high-efficiency outcomes.
Our partner’s platform is designed to integrate interactions between patients, sites, and sponsors, ultimately improving the efficiency of clinical trial operations. The platform aims to: standardize clinical study workflows, expedite patient recruitment, onboarding, and digital consenting processes, boost study participant engagement, improve eCOA data quality, and increase visibility into study operations.
The Challenge
A global pharmaceutical company requested that our partner deliver two clinical trial UATs within a two-week turnaround time. However, our partner does not offer UAT test script creation as part of standard study delivery, nor does it have an internal process for delivering such services at scale. Creating custom UAT test scripts requires specialized expertise to align study-specific requirements with those of the eCOA/ePRO platform being tested—ensuring UAT testers run the relevant and necessary testing activities.
The Solution
Studion’s life sciences project managers drove discussions with our partner to align on the project scope, timeline, budget, and expectations for communicating feedback and collaborating on UAT activities. When conducting UAT under tight timelines, it’s critical for all the parties involved to clearly define and agree on their roles and responsibilities to streamline the entire testing process.
In this scenario, our partner was primarily responsible for conducting pre-UAT activities, providing project design specifications (PDS), and coordinating with client stakeholders. Studion’s SMEs in quality engineering and validation reviewed specifications, created client-facing UAT Overview documents, and developed test scripts for client use. Both teams maintained frequent communication to remain on track, considering the short timeframe for the UAT test script deliverables.
The Impact
Studion delivered all test scripts with quality and ahead of schedule. Studion’s unique expertise in delivering UAT test scripts seamlessly complemented our eClinical partner’s internal capabilities and process, enabling them to offer UAT testing at scale across multiple clinical studies.
Our deep expertise in eCOA/ePRO and the broader eClinical technology landscape enables us to deliver high-quality UAT that meets the rigorous standards of regulated clinical trials, without compromising study timelines. Whether you need a managed service UAT solution or targeted testing expertise, Studion provides flexible, scalable support tailored to your needs.
