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How do CDISC standards fit into the drug development process?

pharmaphorum

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.

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How a clinical metadata repository can help with data quality

pharmaphorum

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.