Building Clinical Supply Confidence with UAT

Clinical supply success isn’t just about inventory levels or shipping timelines. It is built, or undermined, by the decisions made during IRT specification development. It is critical that your IRT scripts for testing incorporate all facets of the IRT specification and study design nuances. These scripts will be validated through rigorous user acceptance testing (UAT) to ensure the system functions as expected.

When supply issues arise mid-clinical trial, they often trace back to a simple gap: assumptions about how the system would perform under real-world conditions. Missed country approvals, dynamic site activity, protocol amendments, and patient behavior are complexities that rarely appear on standard test scripts. Yet they define the operating environment of every global clinical trial.

A prevention-first approach to script writing and UAT can change that. It requires stepping beyond functional testing and designing scenarios that challenge supply chain resilience: modeling how the system behaves when sites close or reopen, when supply lead times vary, when patient visit patterns shift, or when country launches happen out of sequence.

It also requires collaboration. The most effective UAT processes involve input not only from IRT specialists but also from clinical operations, supply chain professionals, regulatory experts, and country leads. Each brings a critical perspective on where operational risks may emerge and how they should be reflected in testing.

In practice, this approach can help mitigate risks that might otherwise result in dosing delays, supply escalations, or protocol deviations. In one recent Phase 3 trial with staggered country starts, mid-study protocol changes, and multiple temperature bands, comprehensive UAT revealed logic gaps that would have caused stockouts in three countries. Addressing those issues before go-live helped ensure over 99% on-time dosing throughout the study.

As trials grow more complex, engineering confidence into the supply chain requires more than verifying that the system works as designed. It requires asking whether it will perform as needed across the full variability of real-world execution. UAT, when approached with that mindset, becomes one of the most powerful tools for protecting patient dosing and operational success.

Let’s make sure your system performs where it matters most. Contact the CSC team today to learn how a smarter UAT approach can help safeguard patient dosing and ensure supply chain readiness from day one.