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Automatically comply with CDISC standards.

With our cloud-based Clinical MDR & automation suite.

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Align with CDISC. Effortlessly.

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.

Win more trials

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.

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 chance of FDA approval

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.

What can I do with ryze?

How you're better off with ryze

Effortlessly comply with CDISC standards

No worries 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.

Some of the organizations using our platform

Testimonials

Effortless CDISC compliance

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

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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

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.

Clinical metadata repository & study 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

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.