TD2 Partners with Medidata to Enhance its Clinical Operations and Accelerate Clinical Trials

Medidata, a Dassault Systèmes company, today announced that Translational Drug Development (TD2), a precision oncology contract research organization (CRO), has signed an agreement to adopt Medidata’s Rave CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File) solutions. Rave CTMS and eTMF are key offerings within Medidata’s Unified Platform, a cutting-edge platform that is transforming the clinical trial experience for patients, sponsors, CROs, and research sites.

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“TD2 has worked with Medidata using their Rave EDC (Electronic Data Capture) system for many years. The addition of Medidata’s CTMS and eTMF platforms will allow for even more standardization across data management and clinical operations, creating efficiency, while reducing integration time and resources,” said Dr. Stephen Gately, President and CEO at TD2. “Medidata has been a key partner for TD2 in supporting our goal of enhancing access to the right care, for the right patient, at the right time. This partnership improves our ability to provide valuable, data-driven insights to our clients, which is critical to the success of clinical trial design and execution.”

Rave CTMS addresses the struggle that study teams experience in trying to efficiently manage and oversee clinical trials due to the fragmented and rapidly changing trial ecosystem. In 2021, Medidata released major enhancements to Rave CTMS including ad hoc reporting and proactive risk management support, enabling users to move beyond static data based on simple calculations to intelligent risk detection and actionable data-driven insight. Rave CTMS:

• Improves speed and efficiency for the oversight of studies and sites, including study/site team creation and activation, patient enrollment and milestone tracking, site monitoring, and issue management
• Serves as a transactional, digital hub to connect users and deliver workflows
• Enables data-driven insights that foster collaboration, visibility, and transparency

Rave eTMF streamlines creating, managing, and populating clinical trial content while providing full support for the Drug Information Association’s (DIA) TMF reference model. Because Rave eTMF is unified with the Medidata Unified Platform, study teams can manage TMF content seamlessly and accurately while maintaining inspection readiness and compliance. Rave CTMS paired with eTMF is the only data-driven solution for faster, smarter, end-to-end trial management.

“TD2 focuses exclusively on oncology drug development and has impressive experience conducting translational studies from bench-to-bedside against all tumor types and hematology indications,” said Martin Dowdall, Vice President, Product Management at Medidata. “We’re excited to work with TD2 to revolutionize its clinical operations technology and expand its capabilities into all phases of clinical development. Our deep experience in delivering CTMS solutions for over 10 years, across 130 customers and more than 9,000 studies, as well as our best-in-class unified platform, make Medidata a natural partner for TD2 as they accelerate patient access to novel therapies.”

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 TD2

TD2 is a leader in precision oncology, providing innovative services for improved drug development. Using a dedicated, expert team with broad experience and understanding in cancer medicine, TD2 is uniquely positioned to support accelerated development of novel therapeutics. Rigorous and high-throughput translational preclinical development services, combined with regulatory affairs expertise, enables customized clinical trial design and execution. The broad suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process with the ultimate goal of accelerating patient access to promising treatments. For more information, visit www.TD2inc.com.

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 1,900+ 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. Dassault Systèmes brings value to more than 290,000 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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