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Effortlessly align with CDISC standards

With ryze cloud-based Clinical Metadata Repository & automation suite

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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.

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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

Only ryze gives you one cloud-based platform where you can do everything in one place, including CRF design, SDTM datasets, EDC study build, SDTM automation – and reuse all your standards, studies and metadata.

Uniquely with ryze, you can design and preview eCRFs in the Clinical MDR itself. You don’t need to wait until the EDC is built to see how eCRFs look – you can see how they look and work for your EDC in the ryze platform.

After designing your study in ryze, you can automatically build your EDC in its entirety from the platform. That includes edit checks and visit schedules for your chosen EDC, which makes ryze unique.

ryze is the only platform that enables you to build your study in just 6 weeks. With faster study setup and build, ryze puts you in the position to start trials in half the time.

ryze is unique in being the only ready-made software solution of its kind that doesn’t require any development – it’s ready to use immediately straight off-the-shelf.

Only ryze handles the full breadth of metadata, including EDC, 3rd party, in-house and CDISC metadata, across all versions of SDTM, ADaM, SEND and NCI Controlled Terminology.

You can import/export and reuse metadata from different EDCs and 3rd party systems with ryze. Uniquely, the platform is EDC neutral, so you can reuse metadata from all the leading EDCs.

ryze is unique in being chosen by CDISC to design CDASH compliant example CRFs. The platform lets CDISC create, preview, edit and approve eCRFs, before exporting in ODM-XML and publishing on their eCRF portal.

Only ryze lets you generate your first SDTM dataset conversions in just 4 weeks – or as soon as patient data is in the EDC. It’s this instant access to real-time data insights and the ability to make timely changes to trials that meant ryze was used in recent COVID vaccination trials.

7 compliance challenges commonly encountered and how to overcome them

No need for programming or laborious manual processes

Clinical metadata repository and automation tools

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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.