Almac’s Spotlight on IRT Podcast Highlights Advarra Experts
In the latest episode of The Almac Group’s Spotlight on IRT podcast, Advarra Consulting experts Kathy Kelly and Ellen Liedel-Sargent were called on to discuss their perspectives on preparing interactive response technology (IRT) for regulatory inspections with host, Matt Lowrie.
The role of IRT in research is constantly changing, and ways in which regulators conduct their inspections also continue to evolve. In the podcast, Leidel-Sargent and Kelly describe common concerns and findings from regulatory inspections and discuss ways to avoid such issues, like clearly stating record retention expectations in the contract.
“When preparing for inspection, it’s best to prepare for the most stringent regulatory body that might possibly inspect, and then that way you know you will be prepared,” they explain. “Both of us agree that there are never enough resources to get ready for the inspection. You must have all hands on deck, get your resources in order, go through all your data, and have everyone prepared.”
The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to pharmaceutical and biotech sectors globally.