The Role of Artificial Intelligence in Clinical Trial Transparency – Certara

European and U.S. clinical trial data transparency initiatives -- such as EMA Policy 70 -- are creating additional disclosure compliance requirements for pharma and biotech companies. These transparency initiatives have, at their core, the distribution of clinical trial data for public consumption. Clinical trial data typically are contained within regulatory documents such as Clinical Study Reports (CSRs), Marketing Application Submission Documents (NDAs, MAAs, BLAs, etc.) and others. To achieve compliance with these mandates, pharma and biotech companies will need to anonymize and de-identify data sets in their clinical study reports and submission documents, produce research summaries suitable for a lay audience, and publish their clinical study information publicly. In this webinar, Synchrogenix President, Keith Kleeman will discuss how Artificial Intelligence (AI) and natural language recognition and processing are significantly improving the accuracy and efficiency of successfully anonymizing personally identifiable information, patient protected data, company confidential information and other sensitive information from clinical trial documents for public disclosure.