Five Ways To Get Ready For IRT Regulatory Inspections

By Justine Koor, Director, Quality Assurance, Digital Products & Solutions, IQVIA Technologies, Certified Information Privacy Manager (CIPM)

Preparing for a regulatory inspection that includes your Randomization and Trial Supply Management (RTSM), often called Interactive Response Technology (IRT), can feel overwhelming. However, with the right preparation, you can confidently face the inspection.

Drawing from nearly two decades of quality management experience in clinical software and services, including numerous IRT inspections and audits, this article explores several key principles to help you stay inspection-ready.

Partnering with an IRT system and services provider that offers responsive, knowledgeable support can also significantly ease the burden of inspection preparation.