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With our fully integrated clinical metadata repository & clinical trial automation software
CDISC aligned templates are built into the ryze framework so compliance is enforced throughout the end to end clinical study process. That means you’ll always automatically align with industry standards. That includes all the different versions of CDISC SDTM, ADaM, SEND, and Define-XML. You can cut out laborious manual work and get your compliant studies built and submitted in a fraction of the time it used to take.
Because ryze is built on CDISC standards you’ll have no worries complying with the latest FDA and NCI standards. You can quickly and easily build studies in your chosen version of CDISC. Validation tools flag up any issues and help you get them fixed – as you work. No CDISC expertise is required. So you save lots of time, budget and resources.
ryze automates a lot of time consuming processes from study start to completion. Such as annotated CRFs, EDC design and build, metadata specifications, mapping specifications, SDTM conversion and define.xml. Save time and manual effort on laborious tasks and reduce the need for complex programming. And you’ll be better placed to meet submission deadlines.
ryze keeps up to date with changes to CDISC and NCI standards at all times – so you don’t have to. There’s no need to keep track of all the version changes and to spend precious time manually updating internal systems. It’s done automatically by us in the background.
With built in CDISC and NCI standards, your metadata is guaranteed to be of high quality. You can store and manage your CDISC compliant organizational standards in our clinical metadata repository ready to use again and again. By reusing pre-approved content there’s less chance of manual errors. Your standardized content will be correct and consistent across all your studies.
ryze supports all versions of CDISC standards, including old versions. Our platform is kept in line with all CDISC and NCI standard updates – so you’re always regulatory compliant.
Different CDISC standards are required at different stages of a clinical trial. For successful submissions, studies must adhere to CDISC SDTM, ADaM, Define-XML and SEND standards. ryze keeps you compliant from start to finish, so you’ll automatically comply.
Yes. Templates built on CDISC standards guide you through the process. Just select the version you to work with. You can extend SDTM datasets using NCI controlled terms, and add supplemental qualifiers, value level metadata, etc.
Some examples of the types of validation checks are EDC designs against CRF specifications, EDC clinical datasets against dataset specifications, SDTM dataset designs against CDISC standards (SDTM-IG, NCI Controlled terms etc.), SDTM programming, and SDTM Clinical Data against CDISC (SDTM), NCI standards and FDA or PMDA rules.
Our SDTM mapping tool makes the job of creating mappings much quicker in our easy-to-use framework. Whether it’s simple or complex mappings. You can even see what your EDC datasets will look like early on, and get started on your mappings earlier as a result.
Yes. It’s 1 click to do a conversion and our CDISC validation tools flag up any issues and help you get them fixed.