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Medidata, a Dassault Systèmes company, announced the launch of Medidata Detect, a centralized statistical monitoring solution that aims to improve data quality and promote patient safety in clinical trials for new medicines, vaccines, and medical devices. Medidata Detect, part of Medidata’s regulatory-compliant and unified Medidata Rave Clinical Cloud platform, helps customers manage data quality, monitor site performance, and promote patient safety by uncovering and finding errors, trends, and anomalies in data through statistical algorithms and tests.
Glen de Vries, co-founder and co-CEO, Medidata said, “Detect is another example of our continuous innovation that helps advance clinical trials with increased data accuracy and speed. It’s another way we’re working to get important new vaccines and therapeutics to patients in safer, faster ways.”
A report in the Journal of the American Medical Society (JAMA)* found almost a quarter of new drug submissions required one or more resubmissions before they were approved, with a median delay to approval of 435 days following the first unsuccessful submission. Medidata Detect uses one central system for aggregation and review of any number of data sources, flagging data errors, trends, and anomalies in real time.
* Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE, “Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012.” JAMA.2014;311(4):378–384.
Read the full release, here.