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The Montrium Blog

The most helpful and thought-provoking ClinOps content from our writers on the front-lines of the life sciences industry

You can’t talk about the trial master file without talking about inspection readiness. Every process you create, every improvement you make, every step you take—all of it must be done with the knowledge that what you’re doing could very well be scrutinized in a regulatory inspection. And with good reason! After all, the TMF is the single source of truth for regulatory agencies to see that the trial was conducted in accordance with the applicable regulations and that the safety, wellbeing, and rights of participants were preserved. To ensure consistent inspection readiness, there are a couple of processes you’ll need to master, one of which is the TMF health check. Below, I’ll explain some of the key things you need to know about inspection readiness and TMF health checks in order to wow the next regulatory inspector who comes knocking. Here's what's in the article:

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