Customer Story Data detectives fight falsification in clinical trial reporting In the world of drug development, as in criminology, data integrity is a serious affair. Stringent regulations put in place by regulatory agencies like the EMA and FDA are designed to protect patients from drugs that could do them harm. T o ensure a smooth drug submission and approval process, the more innovative among them – companies like Roche, for example – have adopted new best practices for statistical monitoring. A robust monitoring program is so much more than traditional data cleaning, says Chris Wells, Statistician and T eam Lead for Roche’s Centralized Statistics Monitoring Group. “We need to preserve the quality and integrity of our data by ensuring that we are able to identify any occurr

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