Formedix, a leading provider of clinical trial software solutions, has collaborated with CDISC, the global clinical research data standards development organization, to create a novel portal providing free access to ready-to-use, CDASH-compliant, annotated electronic case report forms (eCRFs). As part of this partnership, Formedix’s innovative all-in-one cloud-based clinical metadata repository (CMDR) and study automation platform — ryze — is being used to design CDASH-compliant eCRFs. Forms can be visualized in real-time in ryze, before being easily exported into any of the leading electronic data capture (EDC) systems, expediting the clinical trial set-up process.
Through the new collaboration, CDISC users can access the unique capability of ryze to design and visualize eCRFs and make any necessary changes to forms without having to build their EDC first. As a result, clinical trial setup can take as little as 6 weeks. Furthermore, the eCRFs are CDASH-compliant, which facilitates submission to regulatory authorities. Importantly, ryze is a commercial off-the-shelf system, meaning it is available for use immediately and can be rapidly configured to meet specific application needs.
Peter Van Reusel, CDISC Chief Standards Officer noted, “We can create, visualize, edit and approve eCRFs in the platform, then export them in ODM-XML to use in the CDISC Library and standards packages. Formedix is one of CDISC’s longest standing members. CDISC is keen to work with technology partners that help pharmaceutical organizations to adopt and keep pace with emerging CDISC standards.”
Designed for ease-of-use and to align with varying application requirements, the eCRFs within the CDISC portal are available in multiple formats, including PDF, HTML and XML.
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