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The FDA requires clinical study data to be submitted in a standardized format. This allows the FDA to receive, process, review and archive submissions efficiently. As part of a collaboration with the FDA, CDISC developed data standards to be used from study design and data collection through to analysis. appeared first on.
And, allows for effective planning, communication, and teamwork. Full traceability throughout the lifecycle process ensures audit compliance and increases the chances of a successful submission to the FDA. You can request a no-obligation demo to see how our automation platform could help you. Conclusion. Seeing data much faster.
It ensures compliance The Food and Drug Administration (FDA) in the U.S. The FDA suggests using measurable data to monitor performance accurately. The FDA recommends ongoing sampling and performance tracking until enough data is gathered. After that, the manufacturer has to make sure everything functions properly.
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