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It’s 2020 and the digital revolution is well on its way. Yet, for clinical trials worldwide, real-time access to data is not the norm – and that lack can create a cascading set of issues affecting every aspect of a study. Critical decisions are too often being made in a digital data vacuum. Potentially catastrophic setbacks.
The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map.
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