Formedix has launched all-in-one cloud-based clinical metadata repository and study automation platform to simplify and expedite clinical trial design and build

Formedix, one of the leading providers of clinical trial software solutions, has announced the launch of ryze, an innovative all-in-one cloud-based clinical metadata repository (MDR) and study automation platform. ryze has been specifically developed to accelerate and streamline the design, build and submission of clinical trials, in compliance with the Clinical Data Interchange Standards Consortium (CDISC) and NCI Controlled Terminology.

As a fully-integrated software suite, ryze enables the design and build of the full spectrum of case report forms (CRFs), study data tabulation models (SDTMs) and analysis data models (ADaMs), while also automating SDTM mappings and conversions. Built with compliance at its core, the platform features metadata templates with embedded CDISC standards and NCI Controlled Terminology. This enables pharmaceutical, biotechnology and CRO organizations to effortlessly meet their regulatory objectives. Importantly, ryze facilitates metadata standardization, expediting clinical trial set up, enabling data reuse, and improving data quality and consistency.

“Time is of the essence when it comes to clinical trials,” explains Kevin Burges, Head of Product Management at Formedix. “Designing and managing metadata in accordance with stringent regulatory requirements can significantly delay the whole process. Over recent decades, these challenges have triggered a notable shift from manual, labor-intensive paper-based clinical trial set-up processes to digitized approaches that can help pharmaceutical, biotechnology and CRO organizations with their strive to make a difference to patients’ lives. As an all-in-one cloud-based platform, ryze simplifies end-to-end metadata management and fosters cross-collaboration between stakeholders. Ultimately, the platform provides significant time and cost savings, facilitating faster delivery of new therapies.”

ryze is the only platform that allows seamless integration with a wide selection of leading electronic data capture (EDC) systems, including support for the individual functionality of each system. As such, clinical data professionals can use ryze to design CRFs and make any necessary changes before automatically exporting the designs into the EDC of their choice to build their clinical trial. As a result, clinical trial build can take as little as 6 weeks.

Furthermore, 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.

SDTM conversion is enabled at the click of a button, significantly reducing time-to-data and providing clinicians instant visibility of patient data as soon as it starts flowing in from the EDC system. This allows clinicians to gain actionable data insights to drive well-informed, data-based decision making. Owing to this unique capability, an early release of ryze has already been used with great success to rapidly roll-out COVID-19 vaccine clinical trials.

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