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The gold rush for real-world data has just begun: Between 2016 and 2021, RWE studies jumped by 162 percent, and there’s much more momentum to come. But in that haste to engage insights from everyday patients, one regulatory expert and former FDA reviewer suggests data quality may have gotten lost in the shuffle—at great risk and cost. That is, sponsors can jeopardize their programs by not ensuring data is both reliable and relevant, which the FDA dually requires to qualify as ‘fit-for-purpose.’ Inside this playbook, we’ll explore what that means as well as top tips to avoid common data quality missteps when designing, conducting, and submitting modern studies. You’ll learn:
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