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Executive summary In 2025, clinical trial success hinged less on protocol design and more on how sponsors managed oversight. Updated analysis from the Tufts Center for the Study of Drug Development estimates the average daily direct cost of a trial at $40,000 per day(Phase III:$55,716) fragmented oversight is no longer sustainable. The finalized ICH E6(R3) guideline cements Quality by Design and risk-based quality […]
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