Craig Mooney

In an earlier article, we reviewed the randomization risks that could arise if an interactive response technology (IRT) system isn’t designed and/or implemented correctly. Here we address the consequences that trial sponsors could face if their IRT system isn’t adequately designed to handle the many and often complex drug allocation and trial supply aspects of their clinical trials.

This is the first of two articles on the consequences that could arise if an interactive response technology (IRT) system isn’t designed and/or implemented correctly and how a trial could quickly go off track based on risks related to randomization, drug allocation, and trial supply.

Despite pandemic setbacks, teams must reconsider overlooking IRT functionality in favor of meeting timelines.

Stakeholders from across the industry must discuss ownership to ensure effective implementation.