Push a button... out pops define.xml

The hard work’s already done. Now you’re just 1 click away from define.xml

Create define.xml in 1 click

Once you’ve finished your study, it’s all about FDA submission. And that means having your study metadata in STDM define.xml format. Unless you’ve got the right programming skills, this can be a really daunting and time consuming process.

The quick way? Create the relevant define files with ryze visual define xml editor. Once your metadata is in our library, you’ve built your study and defined your datasets, you can create define.xml file in 1 click. No need to understand code or XML. And if you’ve got a spreadsheet, just import it into ryze to convert it. You can even convert a SAS XPT file or old legacy datasets. See how our visual define XML editor gives you faster define.

Want to create define.pdf file for your FDA submission? Just click a different button. Not only do you save time at the end of your study, you have the chance to get your study submitted much sooner too.

What can I do with ryze?

How you’re better off with ryze

Create Define in 1 click - no programming needed

Create SDTM define.xml files at the click of a button in ryze. Our platform has a visual define XML automation tool built in so there’s no manual work involved. And you don’t need to be a SAS expert. Instantly convert Excel or SAS XPT files to define.xml, define.pdf, or define.html with our visual XML editor.

Save time & submit studies faster

Because you create define files much quicker, you can be ready to submit your study to the FDA much sooner.

Effortlessly comply with standards

Because we’ve built the Define-XML standard into ryze, you automatically comply with the rules. You’re using a platform that’s built on the latest FDA and NCI standards. Plus, you’re covered for older standards – we still support those too.

Easy validation

Our validation tools help you check your datasets, and spot any deviations from Define-XML standards. So when you’re ready to create your define file for submission, you can be confident that it complies.

Organizations using our clinical trial software

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University of Alabama logo
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What people say about us

UAB testimonial of ryze clinical MDR
Testimonial of CDISC for CRF portal
UCB testimonial ryze clinical mdr
Define-XML free guide

Find out the 6 dos and don’ts of Define-XML

Download our guide to learn all the essentials for creating your Define.xml files. 

How to create Define & other standards

define.xml in ryze

Create SDTM define.xml in 1 click with our visual XML editor

Instantly make SDTM define.xml and ADaM-based define.xml from your ryze datasets.

Convert my data to define.xml

We can create submission deliverables, including define.xml for you. Request a free demo.


How will ryze help me comply with the Define-XML standard?

The Define XML standard is built into our platform. That means you’ll automatically comply when designing your metadata. So less effort is needed in the future to create define compliant metadata – compliance is built into your dataset design by default.

What is SDTM define.xml?

SDTM define.xml is a document that describes the structure and content of data collected during a clinical trial and is required for a regulatory submission. The SDTM Define standard supports the submission of clinical trial data in CDISC SDTM for regulatory submissions.

What are the benefits of the visual define.xml editor?

The FDA requires all submissions to use Define XML to describe datasets. In ryze, you can quickly define your SDTM, SEND and ADaM datasets upfront using the visual define.xml editor. And you’ll be confident knowing your submission will be compliant.

Can you generate SDTM Define-XML metadata directly from XPT datasets in ryze?

Yes, our visual define.XML editor lets you do this. And it’s easy to understand the content of datasets and use them appropriately.

What are "where clauses" used for in Define-XML 2?

They are used to specify when a specific Value definition applies.

How do you handle data from multiple sources in Define-XML 2?

By using “where clauses”. You need to create 2 values with the same name – however they must have different OIDs. Find out more about Describing Multiple Origins for a Value in Define-XML 2.