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Want 1 cloud solution to design CRFs, reuse content, build EDCs and automate SDTM?

Our NEW ryze Clinical MDR & automation suite gives you everything in 1.

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Introducing ryze - the NEW all in one cloud suite to standardize & automate clinical study build

ryze is the only out-of-box software suite that lets you design CRFs, SDTM datasets, and ADaM datasets, as well as automate SDTM conversions – all in one single cloud platform. ryze has been developed to speed up and streamline the design, build and submission of clinical trials, whilst also improving quality and consistency across studies and standards.

Did we mention it has built-in CDISC compliance! Built with compliance at its core, ryze features metadata templates with embedded CDISC standards and NCI Controlled Terminology. So you automatically comply with the relevant versions of CDISC. And because ryze is cloud-based there’s zero install. Plus it’s off-the-shelf, so it’s ready to go when you are!

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Standardize & reuse content

Once metadata content is approved, you can standardize it and reuse it forevermore. It’s there in your clinical metadata repository (CMDR) for everyone to instantly find and manage – like a ‘single source of truth’. Just choose the relevant standards and metadata from your standardized library to quickly and easily build your new study. That means less effort and manual work, and faster trial set up – a major head start if you like! Not to mention improved quality and consistency.

Effortlessly comply with CDISC standards

ryze is built with CDISC compliant metadata templates – including SEND, SDTM, ADaM, Define-XML and NCI standards. Just choose the relevant version of CDISC for your study. With ryze, compliance is enforced throughout design and build, all the way through to submission. Our validation tools highlight any issues and prompt you to fix them as you go. And ryze stays aligned with new versions and updates to standards, so you’ll automatically comply with regulations. No CDISC expertise is needed. And no manual work is needed to keep systems or studies updated with changes to standards. That means significant time and cost savings, plus greater quality and consistency in your studies and standards.

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Get instant data visibility

ryze significantly cuts lag time, giving you a head start on study build. See exactly how CRFs look in your EDC – including edit checks, controlled terms and visit structures – as you design in ryze. So review cycles can be much quicker. You get to design in the market leading EDCs in ryze – including Rave and Inform. And because you can see what forms look like from the start, you can predict the raw structure of datasets. So you get a head start on mappings – no need to wait for EDC build – and then you can convert your SDTM datasets early too. ryze gives immediate visibility of patient data as soon as it’s live in the EDC, enabling clinical decisions based on real time data insights.

What can I do with ryze?

What can ryze do for you?

Reuse standardized content

Standardize approved content in your clinical MDR, then reuse it across your standards and studies. There’s no need to start from scratch for new studies, or wade through previous files. Just choose the relevant pre-approved content from previous studies to design your next study.

Design in leading EDCs

Build your study in a choice of leading EDCs, including Rave and InForm. You can even use different EDCs for different study phases. Instantly see how your CRFs look and work as you design them in ryze – then make and view changes directly in the ryze platform. When you’re happy, it’s just one click to build your EDC.

Quickly find and share content

Because your content is stored in one place, it’s quick and easy to find, share and manage metadata. No need to rely on others or waste time searching through files to find what you need.

Easily manage changes and see any impacts

See how proposed changes will impact standards and studies before you make them. Fully control and track all changes – see who made them, and when. ryze gives you full end-to-end traceability, resulting in improved consistency and better decision-making capabilities.

Build datasets faster

Build SDTM and ADaM datasets quickly using our built in templates. ryze guides you through the process, so you can’t go wrong. You can see exactly how your datasets look as you define them.

Instant SDTM conversions

See your source SDTM datasets before collecting any patient data. That’s a big head start on SDTM dataset design. ryze ‘predicts’ the raw structure of datasets. So you can start your SDTM mappings early too. Then, it’s just one click in ryze to do your SDTM conversion.

Get define.xml in 1 click

Once your datasets and mappings are ready, it’s just 1 click of a button to generate submission-ready define.xml. And you can instantly convert Excel or SAS XPT files to define.xml, define.pdf or define.html.

Automatically comply with CDISC

ryze is built on CDISC compliant templates, so you’ll always align with the relevant version of CDISC SDTM, ADaM, and NCI standards. Our validation tools instantly highlight any issues throughout your study, so you can fix as you go and avoid submission delays at the end.

Easily integrate with other systems

Work effortlessly across 3rd party systems. Our APIs let you integrate with other EDCs, e-clinical systems and your internal systems, so you can instantly transfer clinical data into ryze. This saves huge amounts of time and means you can set up automatic processes.

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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 XML technical 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.

See ryze in action

Design, build and manage your metadata. All in one place.

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.

Some of the organizations using Formedix

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Testimonials

FAQs

Does ryze stay up to date with all versions of CDISC?

ryze supports all version of CDISC standards, including old versions. It’s kept in line with all CDISC and NCI standard updates – so you’re always compliant.

Do I have to use all of the features in ryze?

No. We understand that different organizations have different needs. You can access all of the features in ryze and choose the ones you want to use. For example, some organizations might just want to use the metadata repository to store and manage standards. Some might want to design and build EDC studies. And others might want to use all of the features for their end-to-end studies. It’s entirely up to you.

Can my system integrate with ryze?

Yes. You can log in to your own system and our API automates the upload, conversion and download of clinical data.

What support is available for ryze?

We have a professional services team in place to help and support you. And you get your own dedicated account manager. If there’s something you need doing, it’s no problem. Just let us know what it is.

Can I standardize my content in ryze?

Yes. You can create content from scratch in ryze and standardize it using configurable governance processes that you can set to suit your organization’s needs. You can also import standardized content from your EDC or e-clinical database. By using pre-approved content, you know it’s complete and correct.

Are SDTM conversions automated?

Yes. Once you’ve set up your mappings, it’s just 1 click to convert your compliant SDTM datasets.

Everything you need in 1 integrated software solution

Design, build and manage your metadata. All in 1 place – over the internet.