Formedix ryze cloud platform is here!  Learn more 

Effortlessly align with CDISC standards

With ryze cloud-based Clinical Metadata Repository & automation suite

validate-cdisc-sdtm-study-build

Automatically comply with CDISC - no knowledge needed.

CDISC aligned templates are built into the ryze framework. So compliance is enforced throughout the clinical study process. That means you’ll automatically align with industry standards, including all the different versions of CDISC SDTM, ADaM, SEND, and Define-XML. Now you can get compliant studies built in a fraction of the time!

Easily comply with regulatory standards

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.

Save time & effort

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.

Avoid CDISC version updates

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.

Gain better quality metadata

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.

What can I do with ryze?

How you’re better off with ryze

Build datasets faster

Choose rule based templates in the relevant version of SDTM and ADaM to build datasets quickly and accurately. You can see exactly how your datasets look as you define them. ryze guides you through the process, so you can’t go wrong.

Effortless validation

Our validation tools constantly check your CRFs, EDC designs and datasets to make sure they comply with the relevant version of CDISC. If you make a mistake, no worries! ryze instantly lets you know what the error is and where to fix it.

Comply with all versions of CDISC

ryze supports all current and previous versions of CDISC standards. Our platform is kept in line with CDISC and NCI standards at all times. Simply choose the version you want to work with, and our templates keep you compliant every step of the way.

See difference reports

Instantly see granular difference reports showing changes to CDISC standards, NCI Controlled Terms and internal organizational standards over time.

Avoid submission delays

Because CDISC standards have been built in from the start of your study, there’s less chance of quality issues and submission delays at the end.

Reuse standards

You can store your approved content as organizational standards in ryze. Reuse forms, datasets, mappings, and more – safe in the knowledge they are correct and consistent. That means increased metadata quality plus you’ll save a ton of time and resources.

Do mappings easily

Our mapping tool lets you map your source datasets from your EDC system to SDTM datasets and from ADaM datasets back to SDTM easily. You can see what your EDC datasets will look like early on so you can define mappings earlier. Once they’re done, you can standardize and reuse them. You’ll save time and money and you can run a report to ensure mappings are accurate.

Instant SDTM conversion

You can convert your SDTM datasets with 1 click. And, because they’ve been designed and built using the correct version of CDISC, your converted data is automatically compliant too.

Get define.xml in 1 click

Once your datasets and mappings are set up, it’s just 1 click to generate compliant define.xml in Excel, PDF or HTML format. You can even convert Excel or SAS XPT files instantly.

Some of the organizations using our platform

Testimonials

Effortless CDISC compliance

We manage your CDISC compliance. So you don’t have to.

member-cdisc

Don’t worry about meeting the latest FDA data standards. Formedix supports all versions of CDISC standards. And we keep our platform updated in line with CDISC and NCI standards. That way your study designs and datasets are always regulatory compliant.

As one of the first CDISC members back in 2001, you can rely on our deep rooted knowledge of all things CDISC. We’re members of the CDISC Data Exchange Standards team. As such we’ve been involved in developing many key features in CDISC ODM and Define models. This makes us well placed to give real-world, practical CDISC training. Click below to find out more.

Why you get more with ryze

ryze is the only platform that lets you design CRFs, create SDTM datasets, reuse content, as well as build studies for leading EDCs, and automate SDTM conversions – all in one cloud suite.

ryze is the only Clinical Metadata Repository that lets you design and visualize eCRFs inside the platform. You can see exactly how eCRFs look, and how they work for leading EDCs – without having to build your EDC and go back and forth between platforms to edit and review.

With ryze, you can build your study in a fraction of the time it normally takes – in as little as 6 weeks! Building studies from standardized content not only speeds up design, but also increases quality and consistency across studies and standards.

ryze is the only platform that supports such a breadth of CDISC, 3rd party, and in-house metadata. You can design CDISC metadata in any version of SDTM, ADaM, SEND, or NCI Controlled Terminology. Plus, you can design edit checks, EDC specific metadata, 3rd party lab transfer specs, mapping metadata, and analysis results metadata to name a few examples.

With ryze, you can transfer metadata between various platforms – such as EDCs – and continually reuse it. There’s no need to redesign, retype, or retest content if you switch EDCs for example. Just move your assets and reuse them. ryze is the only EDC vendor neutral platform that gives this level of reusability across systems.

ryze is the only commercial off-the-shelf solution that’s available for use immediately, and requires very little ryze can be very quickly tailored to your specific needs, with no long or complex implementation.

ryze is the only solution used by CDISC to design CDASH example CRFs. They create, visualize, edit and approve eCRFs in ryze, then export them in ODM-XML to publish on their CDASH eCRF portal.

You get your first SDTM dataset conversions much faster with ryze – in as little as 4 weeks, or even less! As soon as patient data is live in the EDC, you can see it. So you can act upon trial data far quicker. In fact, our platform was recently used to determine safety and efficacy in several COVID vaccination studies.

7 compliance challenges commonly encountered and how to overcome them

No need for programming or laborious manual processes

Clinical metadata repository and automation tools

Got a project in mind?

Tell us your requirements or what’s giving you grief, and we’ll see if we can help.

FAQs

Which versions of CDISC and NCI standards does ryze support?

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.

Which CDISC standards are required for regulatory submission?

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.

Is it easy to create datasets in ryze?

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.

What types of validation are available in ryze?

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.

How does ryze help with mappings?

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.

Can I convert legacy studies to be CDISC compliant?

Yes. It’s 1 click to do a conversion and our CDISC validation tools flag up any issues and help you get them fixed.