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

With our clinical metadata repository (MDR) & study automation platform.

Why Formedix? 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 the Formedix family to the next level… on ‘the cloud’ we go! 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!

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.
Drum roll… we’ll launch our cloud-based clinical metadata repository (MDR) and study automation platform this year!

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.

Why we're different

Some companies say they do things differently, when really it’s just the same. We actually are different. Find out below what sets us apart.

It takes a fraction of the time to set up your study in Formedix 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 builds your study in just about any EDC system – 7 to date – saving loads of time. Use your favourite, or even different EDCs for different studies.

Only Formedix lets you import (as well as export) files directly from Rave and InForm. And that’s without you even needing to go into your EDC. You can do it straight from our platform. Not only that, our preview feature shows what your eCRFs will look like in your EDC system before you’ve built your study. 

Our platform is aligned with updates in CDISC standards, so you’ll always be compliant. And we’re the only ones who support both new and old versions of CDISC standards too.

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 metadata repositories, but they’re like disconnected libraries. We’ve put everything in 1 place, where all your assets are truly interconnected. You and your co-workers can see and work on everything at once.

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 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.

What's your story?

Tell us what you’re trying to do, and we’ll show you how we can help.

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

Some of the organizations using Formedix



Effortless CDISC compliance

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


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. See our CDISC membership certificate for the year 2020-2021. Click below to find out more.

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Frequently Asked Questions

How long has Formedix incorporated CDISC standards?

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!

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 Formedix support?

Formedix 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. Formedix has CDISC standards built in to keep you compliant from start to finish!

See Formedix in action

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