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Did you know the FDA is making CDISC compliance mandatory for all submissions? How does your data stack up? The good news is, ryze can help. Our platform is built on CDISC templates – compliance is enforced from study start to finish with the latest CDISC SDTM, CDISC ADaM, and NCI standards. No expertise needed. And with automatic processes, you’ll be able to save precious time, budget and resources.
Our platform has CDISC compliant templates letting you build studies in both current and previous versions of CDISC. Choose the relevant version of SDTM, ADaM and SEND standards and our templates guide you every step of the way. If you make a mistake, our validator tool will alert you instantly. You can even see reports showing changes to CDISC and NCI standards. Now you’ll be in a better position to win more trials from the NIH.
ryze has automated processes to streamline studies from beginning to end. Less expertise is required for programming tasks. And you won’t need to spend money on expensive CDISC training courses. You’ll be able to make budget cuts allowing funding to stretch further than before.
Every stage in the clinical study build process is faster in our platform. Like CRF design, specifications, datasets, mappings, SDTM conversion and define.xml. And with CDISC expertise built in, you’ll save a ton of time. By saving time and resources, you’ll be much better placed to bid for more grants.
Because our platform is built on the latest CDISC standards, your study design and data automatically comply with FDA regulations. This helps to increase your chances of a successful, approved submission. And you’ll be in a better position to win more grants.
We are using the Formedix platform to design CDASH-compliant, example CRFs for the CDISC eCRF Portal. 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.
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities.
You can get started immediately. Our platform is off-the-shelf. Import your content and use our built in templates and validator tools to align with CDISC standards. By standardizing content, you can reuse it again and again across all your studies. That way it’s guaranteed to be higher quality and increases the chance of successful submission to the FDA.
Our platform automates many manual programming tasks that highly skilled, highly paid developers do. And because CDISC standards are built in, it means that a high level of expertise is not required. You can save training and staffing expenses, as well as a lot of time.
The FDA is making it mandatory for clinical trials run by academic institutions to comply with CDISC SDTM, ADaM, Define-XML and SEND standards.
Our SDTM mapping tools automatically create the specifications for you. No double coding needed. That means you get your SDTM dataset conversion in as little as 4 weeks – maybe even less.
Yes. When you create a study build in Formedix, it’s in ODM format. All you need to do is import it into the EDC of your choice. Formedix integrates directly with 7 leading EDCs including OpenClinica. So for example, you can import content directly from OpenClinica and see how your CRFs will look and work – in Formedix. Then, make any required changes and build your OpenClinica EDC in 1 click.
You can quickly and easily see all the specifications your teams need – in 1 click. See your CRFs as you design them in Formedix. See metadata specifications, visit structures, annotated CRFs, edit check specifications, and mapping specifications.