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 synchrogenix president


AI solution redacts 'hundreds of studies per day,' Synchrogenix President

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Certara's regulatory and medical consultancy, Synchrogenix, introduced the artificial intelligence-enabled solution to meet new data transparency requirements released in January 2015 by the European Medicines Agency (EMA). The new transparency and disclosure rules, Policy 70, requires clinical study report publication for all successful marketing authorization applications submitted on or after that date. On March 2, 2016 the EMA published clarifications to Policy 70, which, as Synchrogenix President, Kelley Kendle, told us, expands on the type of clinical trial data to be published to include not just clinical study reports, but also patient narratives and other regulatory documents. However, in order to be compliant with Policy 70, sponsor companies will be required to redact patient information and confidential company information throughout these documents before publication. In response to the new regulations, Synchrogenix developed a knowledge-based technology system, which applies learned protocol to the redaction of such confidential information. The AI solution "applies machine learning that can't be duplicated by humans," explained Kendle.