Medidata Launches New Clinical Operations Technologies to Address Critical Issues in Clinical Trial Oversight

Medidata Detect and Rave CTMS Have Improved Study Execution Through Role-Based Monitoring Workflows and Clinical Data Visualization for Hundreds of Customers Across More Than 9,000 Studies

Medidata, a Dassault Systèmes company, announced technology enhancements that address key issues in clinical trial management and oversight. Enhancements to Medidata Detect and Rave CTMS (Clinical Trial Management System) will improve both data oversight and reporting for sponsors and contract research organizations (CROs) in two meaningful ways: how they comprehensively monitor their trial data, and how they visualize those data to make faster decisions.

“Today’s clinical trials are faster and have vastly more data than ever before, creating opportunities for quicker development of new therapies and improved patient experiences. All of this requires a seismic shift in how clinical operations teams can - and should - monitor and report on those data to derive actionable insight,” said Lisa Moneymaker, senior vice president, R&D, Clinical Operations Technologies, Medidata. “Enhancements to Medidata Detect, combined with the launch of Visual Analytics for Rave CTMS, streamline role-based workflows for data monitoring and significantly enhance clinical data visualization, providing clinical operations and data management teams with faster access to actionable insights.”

Medidata Detect provides end-to-end data and risk surveillance, giving cross-functional operational teams the ability to monitor and mitigate risks to patient safety and data integrity. This release has created an entirely new role-based user experience, with four unique modules for data review, data analyses, site performance monitoring and protocol risk monitoring.

Visual Analytics for Rave CTMS is a powerful new data visualization tool that allows users to quickly and easily navigate, explore, and combine data through intuitive visuals, charts and tables. With this launch, study teams have enormous flexibility to visualize all available data within Rave CTMS, and interrogate them in ways that make the most sense for them and for their organization.

Both offerings are part of Medidata’s award-winning Digital Oversight Solution, which has been shown to reduce on-site monitoring days by 33% per site/year (a total of four monitoring days), with no impact to study quality. Medidata’s Digital Oversight Solution unifies risk management, centralized monitoring, remote monitoring and a robust CTMS on one platform. The unified solutions move teams away from delayed, reactive methodologies to proactive and predictive strategies, and supports the execution of decentralized and hybrid trials by ensuring no information is lost, dropped or without clinical context.

Medidata is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.

About Medidata

Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 2,000+ customers and partners access the world's most trusted platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: FR0014003TT8, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @Medidata.

About Dassault Systèmes

Dassault Systèmes, the 3DEXPERIENCE Company, is a catalyst for human progress. We provide business and people with collaborative 3D virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, our customers push the boundaries of innovation, learning and production to achieve a more sustainable world for patients, citizens, and consumers. Dassault Systèmes brings value to more than 300,000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit www.3ds.com

3DEXPERIENCE, the Compass icon, the 3DS logo, CATIA, BIOVIA, GEOVIA, SOLIDWORKS, 3DVIA, ENOVIA, NETVIBES, MEDIDATA, CENTRIC PLM, 3DEXCITE, SIMULIA, DELMIA, and IFWE are commercial trademarks or registered trademarks of Dassault Systèmes, a French “société européenne” (Versailles Commercial Register # B 322 306 440), or its subsidiaries in the United States and/or other countries.

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