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.

“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.

 

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