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We help you get clinical trials designed, built & submitted faster

With our ryze cloud-based Clinical Metadata Repository & automation suite.

Why ryze? Speed. Compliance. And ROI.

Basically, we come to work every day to make clinical trials less of a headache! Like when you’re trying to juggle lots of files in different places. And get through so many labour intensive tasks. Sound familiar? Like designing CRFs. Clinical study builds. SDTM mappings. Converting datasets to SDTM. Creating define files… It’s not easy.  

But it doesn’t have to be that way. Our clinical metadata repository and clinical trial automation software make it super quick and easy to manage your metadata. And comply with standards. The result? You get loads more done, much faster. That means a quick return on your investment, and a real chance to make great profits. What’s not to love!

How we started

Meet Mark, our founder and CEO. Mark is HUGELY passionate about the industry. He likes the people. Loves talking shop. Quite simply, it’s what makes him happy!  

It all started many moons ago with a pharmacy degree. Next he went to run clinical trials at a pharmaceutical company. He could hardly believe how long it took to set up a clinical trial. Then came the ‘Ah-ha’ moment. The entrepreneur in Mark took over. And from a bedroom in Glasgow, he trail blazed his way into metadata software. He launched the first ever clinical trial design tool based on CDISC standards. That was way back in 2000. And Formedix has been his raison d’être ever since!

Almost 20 years on and he’s still hooked. Now Mark’s taking us on the cloud! Ever more exciting opportunities ahead – for us, for the industry, and most of all for you if you join us!


The journey so far

Innovation is in our DNA. Since the start we’ve set out to keep solving more of your challenges by advancing our platform – often with ground breaking solutions. Everything we do is based around your actual needs and pain points. As you can see below, we’ve listened to what you wanted and added many new features over the years. And there’s lots more to come!

Cool Timeline


Mark Wheeldon forms Formedix in his spare room.

Launched the 1st clinical trial design tool based on CDISC standards. You could create & preview study specs, cutting study set up time by up to 7 weeks!

Introduced the ability to design datasets based on the CDISC Define.xml data model.

Added a range of solutions to automate EDC build – it’s no longer manual.

Made integrations with every major EDC system, including Rave, InForm, and TrialMaster.

Added the ability to create SDTM datasets for studies. Also made Define.xml file creation possible, supporting the latest version of the standard, Define-XML 2.0.

Launched our fully integrated clinical metadata repository (MDR). Now you can see and manage your metadata in 1 place.

Added impact analysis and change management features to the platform.

Our *NEW* ryze cloud-based clinical metadata repository (MDR) and study automation platform is launched!

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 configuration. 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.

Some of the organizations using our platform


Effortless CDISC compliance

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


Don’t worry about meeting the latest FDA data standards. ryze supports all versions of CDISC standards. And we keep ryze 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. See our CDISC membership certificate for the year 2020-2021. Click below to find out more.

Hi, great to meet you!

We’re the leadership team at Formedix. We’re a super friendly and helpful bunch – we definitely make business more human! We’ve got tons of experience and use it to make clinical metadata management that wee bit easier.
Can you guess what we all get up to in our spare time?!…


Mark Wheeldon


Darren Bill

Head of Operations

Kevin Burges

Head of Product Management

Rachael Yates

Marketing Manager

Greg Blincow

Development Manager

Eric Harold

Test Manager

Values that drive us


We love what we do, love our community, and seeing the difference we make for people in the industry.


We’re always adding new stuff – mostly from your feedback. And our product road map promises lots more features to come.


You need us to be honest and clear, and that’s exactly how we are. We do what we say, and if we can’t do something, we’ll tell you.


We genuinely care about you succeeding, and we’re on your side – think of us as an extension of your team.

Added value

We get on with things and get them done, no messing. And we’re fast, so you get more done, faster, and get a quick ROI.


How long have CDISC standards been incoporated?

Formedix was one of the first CDISC members back in 2001. We launched the first ever clinical trial design tool based on CDISC standards in 2004. From there we’ve continued to stay ahead with all things CDISC! For example, we introduced the ability to design datasets based on the CDISC Define.xml data model in 2008. We added the ability to create SDTM datasets for studies. And also made Define.xml file creation possible, supporting the latest version of the standard, Define-XML 2.0. That’s a lot of history and expertise gained over the years that lead to our latest development ryze – our all in one cloud suite.

Is Formedix involved with the CDISC XML team?

Yes. Being part of the CDISC XML team means we’ve been involved in developing CDISC ODM and Define models.

Is Formedix involved in CDISC 360?

Yes. CDISC is using Formedix to design annotated CDASH CRFs, and to view and review their CRF library. They’re also managing updates and versioning using our platform.

Which versions of CDISC standards does ryze support?

ryze supports all versions of CDISC standards, including old versions. Our platform is updated in line with CDISC and NCI standards. That means your study designs and datasets are always regulatory compliant!

What CDISC standards are required for regulatory submission to the FDA?

CDISC SDTM, ADaM, Define-XML and SEND must be implemented, and adhered to, at specific stages during a clinical study. ryze has CDISC standards built in to keep you compliant from start to finish!

Got a project in mind?

Tell us your requirements or what’s giving you grief, and we’ll see if we can help.