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One governance-focused industry analysis puts it directly: without Quality by Design (QbD) principles built into study design from the start, decentralization becomes fragmentation a patchwork of one-off systems per trial rather than a scalable, repeatable model

Scientific Reports, 10 (1), 1-13

The changes are more so the 99024 required reporting and the harsh rules on documentation, which require providers to remain alert in order to prevent denials and audits

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B., Hu, J

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