Simplify your TMF completeness and compliance.
Easy-to-use Rave eTMF (electronic Trial Master File) 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 Rave Clinical Cloud, you can manage TMF content seamlessly and accurately while maintaining inspection readiness and compliance.
Why Rave eTMF?
Reduce TMF Operational Burden
Rave eTMF accelerates study start-up by combining content and data from the study’s entire life cycle. Through simplified master data management, automation, and integration, Rave eTMF streamlines your operational processes, such as study and master data set-up, document filing, and reclassification. It does all this while providing you visibility on study completeness, timeliness, and quality.
Strengthen Real-Time Collaboration
With Rave eTMF, site administrators, sponsors, and CROs can create, store, view, edit, and jointly work on an entire TMF life cycle in a single application with cutting-edge UX and automation capabilities.
Comprehensive Search Capabilities
Rave eTMF’s advanced search algorithms—based on content, title, or metadata—makes searching TMF artifacts simple, accurate, and robust. Powered by auto-naming and metadata, it provides standardized content, so you can easily search and manage both regulated and non-regulated content in a single platform.
Getting more from Medidata Rave Clinical Cloud with Rave eTMF
Site activation, enabled by Rave eTMF, Rave CTMS, Rave eConsent, and Rave Site Grants
The Medidata Rave Clinical Cloud platform automates and regulates your site activation process by speeding up document review and increasing transparency between business partners while ensuring compliance. Manage approvals and site activation checklists in Rave CTMS and Rave eTMF. With Rave Site Grants, you can drive faster negotiations with Fair Market Value (FMV) pricing. Our Rave eConsent tool helps you reduce the risk of multiple consent versions through approval.
Efficient study conduct, enabled by Rave eTMF, Rave CTMS, and Rave EDC
The benefits of a unified platform data-driven strategy expand into TMF. Rave CTMS combined with Rave EDC and Rave eTMF delivers the industry’s most comprehensive platform from study planning to close, by unifying content, data, and workflows accurately. Rave CTMS works seamlessly with Rave eTMF to provide TMF auto-population of key artifacts, such as site qualification visits, site initiation visit, and site interim monitoring documentation. This process helps you accelerate trial timelines and minimize risk. Rave CTMS is powered by a data-driven strategy that ensures you can find, access, and reuse EDC data when you need to, eliminating costly integrations, duplicate data entry, data reconciliation, and manual tracking activities.
Co-founder Glen de Vries gives a tour of the Medidata ecosystem in this demo video