See your data. Faster.

With the help of our clinical trial automation software.


Fast data, less effort

There’s a lot of labor intensive processes involved before you have your nice datasets. There’s manual mappings to do. Converting datasets. Getting your Define. Publishing PDFs. It all takes time. Formedix does all these, and more. So you get your datasets and metadata, 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 Formedix. 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

Formedix 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 Formedix, 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 Formedix?

What's in it for me?

Automatically create datasets

Rather than having to work out your source dataset column headings, and do your mappings manually, Formedix 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. Formedix 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 Formedix, 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. Formedix is built on the latest CDISC compliant templates, so you automatically comply with the latest FDA and NCI standards.

What is a clinical metadata repository?

The Formedix platform incorporates a clinical metadata repository (MDR) – a single source of truth! Its core features help to optimize the clinical trial process, and bring life-saving products to market, faster.

Your whole team can access all your standards and studies in one place, on the web. The metadata repository allows you to do lots of different things. For example, you can control access, assign work to individuals, allow parallel review, perform impact analysis, and version all of your content.

Global search functionality makes it quick and easy to find studies, standards, and assets in your metadata repository. This gives greater transparency, control and better communication amongst your team. In doing so you produce higher quality study designs, which gives you more consistent data for your submissions.

Metadata repository & study automation tools

Fast track your datasets

With automatic processes to replace manual tasks.

Some of the organizations using Formedix



Why we're different

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 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 in 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.


instead of 1,484 EDC labor hours


instead of 486 SDTM labor hours


weeks instead of 20 for EDC go-live


weeks instead of 8 to see SDTM data

Frequently Asked Questions

How does Formedix help speed up EDC builds?

Formedix 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 Formedix help me stay aligned with CDISC standards?

Formedix 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 Formedix?

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 Formedix 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 Formedix help me define mappings earlier?

Formedix 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!

What's your story?

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