The Critical Risks of Not Using a Third-Party IRT UAT Provider

Eyedropper dropping liquid into test tubes

As clinical trials become more complex and costly, it is more important than ever to ensure that the study’s randomization and trial supply management (RTSM) logic is fit-for-purpose and matches the protocol. No study sponsor can afford system errors that threaten patient safety, jeopardize study timelines, or call data integrity into question.

That’s what makes user acceptance testing (UAT) so vital. An effective UAT helps sponsors avoid costly errors and delays, and gain confidence that the software will perform as expected. An effective UAT also ensures you will be able to demonstrate the validation during an audit.

The question is: Who is best suited to conduct UAT for clinical trials? For many reasons, outsourcing UAT to a third-party provider is the most effective way to reduce jeopardizing your clinical trial, patients, and reputation.

How Study Sponsors Approach UAT

While every organization is unique, the sponsor company’s size tends to influence how it handles UAT.

Large pharmaceutical companies may have in-house teams dedicated to UAT. Yet those same professionals are usually juggling responsibility for managing the IRT vendor and the quality of the study, stretching their finite resources.

Mid-sized pharmaceutical companies sometimes tap the clinical supplies team for UAT, especially if they view IRT as primarily a clinical supplies management tool. But while this team knows the ins-and-outs of clinical supplies, they don’t have expertise in the specialized skill of conducting UAT ensuring the randomization, supply management, and even the study blind are protected.

Smaller pharmaceutical and biotech companies might look to their IRT vendor for UAT help, since they don’t have in-house experience bringing many products through the clinical trial phase. But having an IRT vendor conduct UAT poses a conflict of interest, since the vendor is incentivized to ensure they don’t jeopardize their own delivery timelines. Consciously or subconsciously they will not challenge the system the way an independent second or third party would.

No matter the size or maturity of the sponsor organization, it’s common to underestimate what can go wrong when UAT isn’t done properly. When an RTSM error causes a clinical trial problem, the consequences can be dire for patients and the sponsor. This can include inadvertently unblinding sites through resupply quantities or notifications or compromising patient safety from mis-dosing. While a large, established pharmaceutical company can likely stay afloat even after a massive study failure, smaller companies that place their bets on one or two drugs will be less capable of bouncing back.

The Risks of Not Outsourcing UAT

Clinical trial sponsors that attempt to handle the UAT function in-house or rely on test scripts provided by the IRT vendor may increase the odds of encountering a problem after the trial goes live. Risks like the following are common when a study sponsor doesn’t outsource UAT to an experienced third party.

You could get a compliance “checkmark” and still have undetected problems. Of course, it’s important that your UAT results pass an FDA inspection. But from a safety and data integrity perspective, the bar must be much higher. It’s possible that the testing could earn a thumbs-up from regulators, even if the system is not 100% fit-for-purpose. And that risk goes up when the UAT isn’t done by a provider whose primary role is to test RTSM-supported studies across a wide range of drug types.
You could miss core functionality problems. Unless UAT is done rigorously, based on proven best practices, focusing on risks, it’s possible to miss that the RTSM’s core functionality doesn’t meet the study protocol. For example, the randomization functionality might not actually work, rendering the study data useless. Third-party UAT providers staff their teams with experts who are knowledgeable about what biostatistics test and understand how to drill down into details like how the study randomization was done while asking probing questions to ensure it happens consistently from end to end.
You might miss the forest for the trees. Within many companies, it’s common for employees to stay in their own lanes. But that’s a risky proposition when it comes to conducting UAT, since it intersects several functions like Clinical Operations, Clinical Supply, and Biostatistics. When a team of in-house testers only represents one of those functions (such as IT or clinical operations), the holistic view that UAT demands is inevitably lost. A third-party UAT provider avoids this risk by going beyond writing test scripts; they look at the study holistically, reviewing the study protocol in depth, assessing the highest-risk data fields and workflows, and questioning everything based on their experience across many other studies, therapy types, and IRT vendors. When you contract with a third party for UAT, you’re essentially buying their RTSM knowledge and experience and asking them to apply it to your particular study.
You could find out the “what” without knowing the “why.” Testing is a unique discipline—part art, part science—so it’s not realistic to expect employees who are experts in other functions to become experts in UAT. These professionals might find a bug that indicates something doesn’t work, but they don’t have the experience to discover why. A third-party UAT provider can answer both questions, drilling down to see what is happening behind the scenes—not only to correct the problem, but to reduce the risk it will recur.
You’ll waste time reinventing the wheel. Most sponsor organizations don’t need to conduct UAT every day. Instead, one person or a small team is pulled to conduct the testing for the current trial, then they go back to their primary job until the next time RTSM-supported trial. That could be years later! Now, they have to get up to speed on the testing all over again (assuming they’re still with the company). On the other hand, UAT is all the third-party provider’s team does, every day. So, when they take on your UAT project, they’re applying skills, knowledge, and experience they’ve honed over many engagements, across many IRT systems. That means they can work more efficiently and effectively, identifying risks while keeping your study on track.
You’re likely to spend more money. Whether you handle it in house or outsource it to a third party, UAT always involves an expense. But if you attempt to tackle UAT on your own, the testing fails to uncover every problem, the trial moves forward, and then has to halt due to system-related issues, you’ll spend a great deal more to remedy the situation.

Given that the RTSM software is intended to ensure each patient receives the right drug at the right dose and the right interval, the importance of getting UAT right can’t be overstated. One clinical trial allowed providers to up-titrate the drug, but the UAT didn’t ensure the up-titrating was done correctly across every patient. When a provider changed the dosing for one patient, the system mistakenly adjusted it for every patient, leaving many of them ill and the study data unusable. Diligent UAT by an experienced third-party provider would have uncovered this system error before the RTSM went live.

How Poxy Clinical Can Help

UAT is Poxy Clinical’s main business; it’s what our team does all day, every day. That means we have the UAT resources, capabilities, and experience that many sponsor companies don’t have or can’t dedicate internally.

When study sponsors outsource their UAT to Poxy Clinical, they gain confidence that we’ll validate the system is fit for purpose, through a combination of high validation standards, a rigorous methodology, a risk-based approach to testing, and experience across hundreds of RTSM-supported clinical trials. And with Poxy Clinical removing the burden of UAT off your organization, your team will have more time and attention to focus on completing your study efficiently and productively. Contact our team today to book a consultation.