Are You Equipped With An Inspection-Ready IRT?
Today’s race to improve speed and efficiency in drug development can be complicated when adding in things like adaptive design, multiple cohorts, randomization, and detailed dosing instructions. And the data that’s collected in an Interactive Response Technology (IRT) is crucial to supporting a regulatory submission. With this informative article, find out how the newest generation IRT, IXRS® 3, emerged flawlessly from the FDA’s first IRT audit.
You will learn:
- FDA’s expectations of how an IRT should be used
- Cost-savings through the expanded use of an IRT
- FDA’s key areas of focus
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