Medidata Offers Breakthrough to De-Risk Clinical Trial Submissions
MEDIDATA SOLUTIONS (MDSO)
Last medidata solutions earnings: 7/23 01:00 am
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Source: Business Wire
Medidata Edge Trial Assurance uses AI to find data quality issues and helps resolve them before submission to the FDA NEW YORK--(BUSINESS WIRE)-- To help organizations mitigate the risk of regulatory non-approval and delays, Medidata Solutions (NASDAQ:MDSO) is transforming how clinical trial data is validated prior to FDA submission with Edge Trial Assurance. For over a decade, fewer than 10% of clinical trials that enter Phase I achieve FDA approval. Too many new drug submissions receive a rejection letter, request for further analysis, or label restriction, significantly delaying market entry, impacting patients and shareholder value. Often, these issues are not about the efficacy of the treatments or devices but the quality of the clinical data. Medidata offers a new way to preempt submission of data errors, by using machine learning algorithms, put in the hands of Medidata’s team
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