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Effortlessly align with CDISC standards

With our fully integrated clinical metadata repository & clinical trial automation software

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Automatically comply with CDISC - no expertise needed.

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.

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 can ryze help you comply with CDISC?

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.

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.

Comply with CDISC - without being an expert

No need for programming or laborious manual processes

Metadata repository and automation tools

Why we're different

It takes a fraction of the time to set up your study in ryze compared with other systems. Your typical 21 week study takes on average just 14 weeks. And the sooner you start your trials, the sooner you potentially launch products (= faster ROI).

No other platform automatically creates you clinical study build in just about any EDC system – 7 to date – saving loads of time. Use your favourite, or even different EDCs for different studies.

Only we integrate 100% with Rave and InForm. So as well as seeing what something will look like before you build it, you can do edit checks and preview eCRFs too.

Unlike others, we keep pace with version changes with managed CDISC standards, so you’ll always be compliant.

Unlike others, you can truly reuse content and save time. No need to retype spreadsheet contents for example. Simply reuse content from 1 study to another, and even across multiple EDC systems.

Ours is the only fully integrated clinical metadata repository out there. There’s other clinical metadata repository’s, but they’re like disconnected libraries. We’ve put everything in 1 place, where your content is truly interconnected.

We’re the only commercially available off-the-shelf clinical metadata repository. Straight out the box and off you go – we don’t have to custom build it for you from scratch.

Some companies don’t improve or expand their platform. We do, constantly. We’re always working on new stuff, and it’s based on your feedback.

7 compliance challenges commonly encountered and how to overcome them

No need for programming or laborious manual processes

Some of the organizations using Formedix

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Testimonials

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.

Tell us about your project

Tell us what’s giving you grief, and we’ll show you how we can help.