Why legacy data management systems can’t support the directions biopharma is headed

Earlier this fall, the FDA detected potential issues in data generated by two contract research organizations (CROs). Specifically, the agency’s statement noted “significant instances of misconduct and violations of federal regulations, which resulted in the submission of invalid study data to FDA.” Accordingly, the agency advised that all affected sponsor organizations repeat any bioequivalence and bioavailability studies essential for approval, and not surprisingly, to do it through organizations other than the two in question or any others with “unresolved data integrity concerns.”

The above anecdote, which is not an isolated occurrence, highlights the importance of data integrity, the lack of which can derail research and set biopharma organizations back by months if not years. My team’s research has found that up to 30% of work is subject to rework because of data issues, wherein the data describing process execution and outcomes simply can’t be located.1 When yo…

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