Documentation

Guidance

As the UAT primary point of contact, we provide support throughout UAT execution. We manage issue reporting to resolution, enabling the clinical team to focus on their expertise. 

We consult the clinical team on how to document test results and append supporting evidence. Solid UAT documentation mitigates auditor inquiries while adhering to FDA guidelines.

Analysis & Planning

We routinely engage with the RTSM / IRT vendor, and clinical team to understand the study design and requirements. A robust test strategy is defined in the UAT plan.

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User Acceptance Testing (UAT) is a valuable opportunity for Biotech sponsors to validate the Randomization and Trial Supply Management (RTSM / IRT) for use in a live trial. Undetected issues can pose risks to patient safety, and data integrity- potentially costing the sponsors millions of dollars to resolve.​​ ​Poxy Clinical provides UAT services to Sponsor companies running IRT supported trials. We adhere to industry test methodology, industry, and FDA guidance.