Managing clinical data and documents has always been a challenge. But maintaining accuracy and integrity gets even tougher with multiple countries, sites and contractors contributing data for a single product. Add in the potential for multiple protocol amendments, and the risks of failing muster with the FDA are even greater.
But what if you knew exactly what inspectors want to see? What if you could compare your own plan against the data management issues commonly cited in 483s? And what if your people were armed with the know-how to anticipate and prepare for the questions inspectors ask?
You can do it all — starting right now!
In this new resource from FDAnews, you’ll find what you must know to create a clinical data management plan that combines trouble-shooting best practices with insider intelligence of exactly what you’re likely to encounter during an FDA inspection.
From generating raw data and creating analysis datasets, to making final data available for FDA review, you’ll learn what it takes to pass muster. From Day 1 of your trial, the plan will empower your people, track, verify and communicate documents and data to ensure accuracy, integrity and the reproducibility of results. Plus, during the inspection, it will limit both confusion and questions.
Buy now to make sure you can prove the claims you make in regulatory filings by following a clinical data management plan the FDA will approve, including:
Remember, FDA inspectors may arrive with or without advance notice. An inspection can be triggered by cause, as part of preapproval, or just as random surveillance. The time to prepare your plan — and your people — is now!
Creating a Clinical Data Management to Satisfy FDA Inspectors is offered by FDAnews in print or PDF format for $377.
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