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R&D and Clinical Regulatory Insight for CROs

FDA sees negotiating formal “qualification plan” as key process improvement that should ultimately accelerate pace for construction of biomarkers and other drug development tools. But it will take some getting used to.
R&D and Clinical Regulatory Insight for CROs
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Digital Health Regulatory News for CRO Professionals

Digitizing data collection and monitoring has taken longer than desired due to various challenges, including resistance to change, unanticipated burdens and trial complexity, officials from ACRO and Medidata say, countering US FDA Commissioner Gottlieb’s criticisms that CRO business practices are holding back change.
Digital Health Regulatory News for CRO Professionals
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