Formedix ryze cloud platform is here!  Learn more 

Get quicker data visibility with ryze Clinical MDR & automation suite.

Less manual effort and more automation gives you your data, faster!

clinical-trial-automation-biostats-sdtm-dataset-creation

Get instant visibility of data as soon as it’s live in your EDC.

There’s so many manual processes to go through to get your nicely converted SDTM datasets. There’s manual mappings. SDTM conversions. Sometimes double mappings…it all takes time. ryze helps you with all this and more. So you get SDTM datasets quicker, with less effort. Download our flyer for more information.

Save time – start analysis sooner

Have your standardized data all ready to start analysis much quicker with ryze. Our automated conversion processes and built in CDISC templates speed up the end-to-end clinical trial process, so you can get on with data analysis much sooner.

Have cleaner data

Not only can you rest easy that your data complies with CDISC, you can be sure of greater quality too. Reusing content cuts down on manual errors. And if you’re reusing content from your organizational standards, it’s all pre-approved.

Less manual effort

ryze automates many of the manual, labor intensive dataset conversion jobs. There’s no need to figure out your source dataset variables (column headings). Or manually do your mappings and double code data conversions. You get these automatically in ryze, so you save loads of time.

Keep up with new standards

Stay on top of new and emerging CDISC standards. Our metadata management tools are built on CDISC foundations. We keep up-to-date with new metadata standards – such as ARM –  so that you can work with these too.

What can I do with ryze?

How you’re better off with ryze

Automatically create datasets

Rather than having to work out your source dataset column headings, and do your mappings manually, ryze helps you do it so much quicker. Zero spreadsheets. Zero double coding.

Effortless data conversion

Once your SDTM mappings are done, convert datasets to SDTM with 1 click. Push the conversion button and out pops your SDTM dataset – no manual labour necessary!

No programming necessary

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.

Get SDTM datasets much faster

You’ll typically wait about 8 weeks for your SDTM datasets. Not ideal when you want to analyze the data ASAP. With ryze, SDTM dataset creation happens in around 4 weeks – often less.

Create define.xml in 1 click

When you’re ready for submission, make your define file at the click of a button. There’s no manual work involved. Just instantly convert Excel or SAS XPT files to Define.xml, Define.pdf or Define.html.

Effortlessly comply with 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.

Some of the organizations using our platform

Testimonials

Fast track your datasets

With automatic processes to replace manual tasks.

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.

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.

0

instead of 1,484 EDC labor hours

0

instead of 486 SDTM labor hours

0

weeks instead of 20 for EDC go-live

0

weeks instead of 8 to see SDTM data

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 does ryze help speed up EDC builds?

ryze lets you predict the structure of raw datasets so you can see how your data looks in your chosen EDC. You can start your SDTM mappings early on. And, you can see patient data as soon as it’s in you EDC. Once your mappings are done, it’s 1 click to do your SDTM conversion. That’s a huge reduction in lag time!

How does ryze help me stay aligned with CDISC standards?

ryze has compliance build in so you’re always aligned with SDTM and ADaM standards. We keep up to date with the latest CDISC standards and support older versions. Our validation tool monitors the quality of specifications, mappings and datasets. It highlights any errors, and tells you where to fix them.  You’ll have quality deliverables and your submission will stand up to scrutiny of FDA regulators.

What are the benefits of managing changes in ryze?

You’ll no longer need to manage and maintain standards manually. CDISC standards are built in and updated so you’ll always conform to FDA regulations. You can instantly see granular difference reports showing every change to controlled terminology and CDISC standards. Plus, any changes made to standards and studies.

How can ryze help save time without losing quality and compliance?

All your standardized content is stored in 1 place. That includes mappings, terminologies, SDTM and ADaM datasets, specifications, and other metadata. Because everything’s standardized, there’s no need for manual creation from scratch. You’ll get around 80% reuse of your standards! That’s a huge time saving. Your standardized content will be consistent, and comply with FDA regulations.

How does ryze help me define mappings earlier?

ryze lets you map your source datasets from your EDC system to SDTM datasets, and from ADaM datasets back to SDTM, easily. Plus, you can see what your EDC datasets will look like early on. This lets you define your mappings earlier.

Which EDCs can I use?

You can build, preview, and validate studies for 7 leading EDC systems. They are Medidata Rave, Oracle InForm, XClinical Marvin, OmniComm TrialMaster, OpenClinica, Parexel DataLabs, and Mi-Co Mi-Forms. All you have to do is pick which EDC you want to use in a particular study phase. You can use different EDCs for different phases in your study. You’re not tied to just 1 EDC at any time!