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

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

Why Formedix 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 Formedix started

Meet Mark, the founder and CEO of Formedix. 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 Formedix on the cloud! Ever more exciting opportunities ahead – for us, for the industry, and most of all for you if you join us. 


The Formedix 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!

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!

Launched ryze labs – our new research function designed to create use cases and prototypes for future ryze features.

Launched Formedix CORE – a free-to-use desktop app incorporating the CDISC Open Rules Engine.

Formedix ryze and Certara Pinnacle 21 data validation platform combine to power faster clinical trials.

Why you get more with Formedix 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.

Organizations using our clinical trial software

moderna logo
UCB logo
vertex logo
University of Alabama logo
cdisc logo
University of Utah logo
argenx logo
idorsia logo
mercator medsystems logo
science37 logo
Catalyst clinical research logo

What people say about us

UAB testimonial of ryze clinical MDR
Testimonial of CDISC for CRF portal
UCB testimonial ryze clinical mdr

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.

Values that drive us at Formedix



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.