Meet Study Timelines While Scaling with User Acceptance Testing as a Service

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 service, including services such as test plans, test script creation, UAT execution and defect documentation, test reports, and project management oversight for eClinical tech providers or study sponsors. With significant expertise conducting UAT for clinical trials, Studion helps these organizations speed up the timeline to first patient-in (FPI) milestones.

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, executed client-facing UAT Overview documents, and created test scripts for client use. Both teams maintained frequent communication to remain on track, considering the short timeframe for the UAT test script deliverables.

Under the arrangement, our partner oversaw all of the UAT design and execution, while Studion was responsible for creating the test scripts. Upon receiving the test scripts from Studion, our partner could then deliver to their client within the short timeline.

The Impact

Studion delivered all test scripts successfully, and even one study 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.

Studion’s extensive knowledge and proficiency with eCOA/ePRO digital solutions means it can provide high-quality deliverables that meet regulatory rigor without risking clinical trial timelines. While Studion provides a full-service UAT offering, eClinical SaaS providers or study sponsors can request Studion’s expertise to support their various UAT needs, regardless of scale.