Automatically comply with CDISC data standards

With our cloud-based Clinical MDR & automation suite

Effortlessly align with CDISC standards

Did you know the FDA has made CDISC compliance mandatory for all submissions? The good news is, our ryze platform can help! It’s built on CDISC data standards templates, so compliance is enforced from start to finish with our CDISC SDTM, CDISC ADaM, and NCI standards templates. ryze even prompts you if you stray from the standards – so you stay compliant throughout your end-to-end trial.

Win more trials

Our ryze platform is built on CDISC compliant templates. Just choose the relevant version of SDTM, ADaM or SEND standards, and our templates guide you every step of the way. If you make a mistake, our validator tool will instantly alert you. And you can even see reports that show changes to CDISC and NCI standards. So with compliance taken care of you’ll be in a better position to win more trials from the NIH.

Maximize resources

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.

Bid for more grants

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.

Increase chances of FDA approval

Because our platform is built on the latest CDISC data 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.

How you're better off with ryze

Effortlessly comply with CDISC data standards

No need to worry about meeting regulatory standards. ryze is built on the latest CDISC compliant templates, so you automatically comply with the latest FDA and NCI standards. And if you’re importing existing content or legacy studies into ryze, our CDISC validation tools flag up any issues and help you get them fixed!

Effortless validation

Validation is built in throughout ryze from the start, so you save time and resource both during and after clinical study build. Now you can submit studies faster, as validation has been done continuously, and not left until submission at the end.

Save learning time and resources

No need to have CDISC or programming expertise. Built in standards and automated processes do all the hard work for you. This saves masses of time and you’ll need fewer resources to conduct your trials.

Save conversion time

ryze shows what your source datasets will be, early on. Before you’ve even collected any patient data, you’ll know what your variable column headings are. That means you can get a head start on designing your SDTM datasets. And start your SDTM mappings early too. By the time you get trial data back, your datasets are all mapped, and it’s just 1 click to do your SDTM conversion in ryze.

Have cleaner data

Because there are no worries about being CDISC compliant, your data will be of better quality. By reusing content, you’ll reduce manual errors. And, if you’re reusing content from your standardized library, it’s already been pre-approved.

No programming required

You don’t need to be an expert in SAS or have any programming experience. ryze automates a lot of the processes that typically require double coding. Like mapping specifications, metadata specifications, and define.xml. And our easy-to-use mapping tools let you create machine-readable mappings, without any coding.

Reuse content

Build your organizational standards in ryze, and reuse them again and again. Whether it’s forms, edit checks, dataset designs, or mappings… do it once, get it approved. There’s no need to create content from scratch each time.

Share content and collaborate easily

Share content and work together from anywhere. ryze clinical metadata repository keeps everything in 1 place, allowing teams to work more effectively and efficiently.

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Hear how the University of Alabama and the University of Utah are tackling CDISC compliance

Watch our free webinar “The need for standardization and CDISC: Insights from The University of Alabama, The University of Utah & CDISC”.

Organizations using our clinical trial software

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Testimonials

Effortless compliance with CDISC data standards

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

member-cdisc

Don’t worry about meeting the latest FDA data standards. ryze 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

Uniquely with cloud-based ryze, you can do CRF designs, build your study for any EDC, create SDTM datasets and automate SDTM conversions, plus reuse content, all in one single platform.

As well as designing CRFs in ryze, you can also see exactly how they look for your chosen EDC – without leaving the platform or waiting for EDC build. This real-time visualization which enables rapid review and approvals is only possible with ryze.

ryze is unique in letting you build a full study from standards in the platform. After designing your study, click a button to automatically build the entire study for your chosen EDC, including edit checks and visit schedules.

With ryze, you can get your first SDTM datasets in 4 weeks or less! Immediately when data is available in the EDC, you can see it and make early informed decisions, in response to safety or efficacy findings for example. For this reason, the ryze platform was used in some prominent COVID vaccination studies.

Only ryze gives you the tools to build your study in just 6 weeks! Reusing standardized content and metadata and being able to automatically build your study dramatically accelerates clinical study build.

ryze supports the full range of CDISC metadata across all versions of SDTM, ADaM, SEND and NCI Controlled Terminology. Uniquely, the platform also handles 3rd party, EDC and in-house metadata, and enables edit check design and analysis results metadata for example.

ryze is the only platform that lets you reuse metadata in its entirety, regardless of EDC system. So, you can reuse metadata content from different EDCs in ryze, without having to retest it.

ryze is the only clinical study software of its kind that’s available out-of-the-box. You can start using it straightaway, without waiting for anything to be built or programmed.

Only the ryze platform is used by CDISC to design, visualize, edit and approve CDASH compliant example CRFs. CDISC exports CRFs from ryze in ODM-XML and publish them on the CDASH eCRF portal.

Clinical metadata repository & CDISC data standards compliance 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

How quickly can I get up and running with ryze?

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.

How can ryze help save resources?

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.

Which CDISC standards are required for the FDA?

The FDA is making it mandatory for clinical trials run by academic institutions to comply with CDISC SDTM, ADaM, Define-XML and SEND standards.

How long does it take to get SDTM conversions?

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.

Can I use study builds in any EDC?

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.

What specifications can I auto-generate?

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.