Clinical trial software solutions provider Formedix has launched a new all-in-one Cloud-based clinical metadata repository (MDR) and study automation platform called ryze.
The company has developed ryze to expedite and streamline the design, build and submission of clinical trials, in compliance with the Clinical Data Interchange Standards Consortium (CDISC) and NCI Controlled Terminology.
The platform, which automates SDTM mappings and conversions, enables the design and build of the full spectrum of case report forms (CRFs), study data tabulation models (SDTMs) and analysis data models (ADaMs).
It is a fully-integrated software suite and features metadata templates with embedded CDISC standards and NCI Controlled Terminology that enables pharmaceutical, biotechnology and CRO organisations to meet their regulatory objectives.
The platform also facilitates metadata standardisation, accelerating clinical trial set up, enabling data reuse, and improving data quality and consistency.
Formedix Product Management head Kevin Burges said: “As an all-in-one Cloud-based platform, ryze simplifies end-to-end metadata management and fosters cross-collaboration between stakeholders.
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“Ultimately, the platform provides significant time and cost savings, facilitating faster delivery of new therapies.”
It also allows integration with a range of electronic data capture (EDC) systems, including support for the individual functionality of each system.
Clinical data professionals can design CRFs using ryze and make any necessary changes prior to exporting the designs into the EDC of their choice automatically to build their clinical trial.
The commercial off-the-shelf system is available for immediate use and can be configured to meet specific application needs.
SDTM conversion is enabled at the click of a button and provides instant visibility of patient data to clinicians immediately after it starts flowing in from the EDC system.
With this, clinicians can gain actionable data insights to drive data-based decision making.