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DATASET TO DEFINE IN 1 CLICK

Once you’ve finished your study, it’s all about FDA submission. And that means having your study metadata in 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 your define.xml file straight from Formedix. Once your metadata is in our library, you’ve built your study and defined your datasets, you can make a define.xml file at the click of a button. No need to understand code or XML. Or if it’s a spreadsheet, import it into Formedix to convert. You can even convert a SAS XPT file or old legacy datasets.

And if you want to make a 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 Formedix?

HOW WE HELP YOU COMPLY WITH THE DEFINE-XML STANDARD

What is define.xml?
Submission of clinical study data to regulatory agencies such as the FDA require not only the clinical data from trials, but also the information to describe the data being submitted. A major component of this additional information is the data definition file – or the define.xml. The define.xml is the metadata describing the content and formatting of the all the submission datasets. Define.xml is prepared by the CDISC define.xml team. Submission of data in the CDISC format requires a define.xml file to describe the Case Report Tabulation Data.

The Define-XML standard
The Define-XML standard is based on the CDISC Operational Data Model (ODM) XML schema. The CDISC Operational Data Model is intended to be vendor neutral and platform independent. This allows the interchange of clinical study data in a non-bias format. Therefore it is required for submission of all studies to the FDA and other agencies. Being a required deliverable, it’s easy to see why being able to quickly and correctly create a Define.xml for your study is so important.

We know Define-XML – so you don’t have to
Formedix has many years of experience and a wealth of knowledge of CDISC standards – including define.xml. We are members of the Define-XML Development team. As such Formedix had a key role in the development of the Define-XML 2.0 (and the upcoming Define-XML 2.1) standard. We’re able to draw on this knowledge to implement the fundamental concepts of the Define-XML standard into all aspects of our products and services.

Automatically comply with Define-XML
Being able to embed the Define-XML standard into our platform helps you automatically abide by the Define-XML standard when designing your metadata. You have an immediate advantage. This also minimizes future effort needed to create Define complaint metadata – you know that compliance will be incorporated into your dataset design by default!

What about updates?
Formedix is at the forefront of updates to standards. We quickly integrate any updates across all aspects of our platform.  And we continue to support previous versions of standards so that you’ve got the flexibility to create define.xml in whatever version you need.

WHAT'S IN IT FOR ME?

CREATE DEFINE IN 1 CLICK - NO PROGRAMMING NEEDED

Make your define.xml file at the click of a button in Formedix. There’s no manual work involved. And you don’t need to be a SAS expert. Just instantly convert Excel or SAS XPT files to define.xml, define.pdf or define.html. 

SAVE TIME & SUBMIT STUDIES FASTER

Because you get your define.xml 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 Formedix, you automatically comply with the rules. You’re using a platform that’s built on the latest FDA and NCI standards.

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.

HOW TO CREATE DEFINE & OTHER STANDARDS

How to create define-xml metadata with Formedix
You can easily create dataset metadata specifications in Formedix. To make things easier, we’ve embedded the Define-XML standards into the dataset design process. This means that anytime you create datasets in Formedix, they will conform to the Define-XML standard. The platform guides you on what to create, so that your metadata is Define-XML compliant.

SDTM, ADaM, SEND & ARM
We’ve incorporated SDTM, ADaM and SEND into an easy to use define structure. All aspects of the define.xml are captured, in order to ensure a valid submission. This covers everything that is needed for the final submission, and also any deviation from the CDISC standards. For example, for ADaM, you can create Analysis Results Metadata (ARM) in Formedix. ARM metadata is only applicable for ADaM, and we’ve given you the tools to describe ARM for a study. This is just one example of how we help you work with new standards very quickly.

Validation of Define-XML
You can check your datasets and note any non- compliance with Define-XML standards in Formedix. This constant guide and ability to validate makes it easy to create valid, consistent Define-XML metadata in Formedix. That way, when it comes to creating your define.xml file, you can rest assured that it will be acceptable for submission. All that’s left is to extract your final define.xml file at the click of a button.

Formedix Professional Services – ask us to convert Excel and SAS to Define-XML
The Formedix Professional Services department can convert various data formats into define.xml for you. We can extract the relevant information from a number of formats – such as Excel and SAS XPT – in order to create a define.xml file for use in Formedix. We can extract the necessary information and infer any other information required to make the define.xml valid.

DATASET TO DEFINE IN 1 CLICK

Instantly make Define.xml and Define.pdf from your Formedix datasets.

Preview Define-XML
Formedix offers many ways to visualize and publish the Define-XML metadata created in our platform. By default, you can preview the define.xml file using the published CDISC stylesheet. This gives a quick and easy way to see your metadata. It includes full definition of the define; page links to annotated CRFs; and hyperlinks to the submission datasets. In addition, we stay up-to-date with any changes to the stylesheet as released by CDISC.

Another way to see your define.xml metadata is to use the Formedix tools to visualize it in PDF format. This also contains hyperlinks for any page references to the annotated CRF. That way you have a nice user friendly way to see your define and share it with colleagues.

Define-XML prediction
Formedix also lets you predict the define.xml that will be created based on your form design. When you create a study in Formedix and design forms for an EDC system, the platform accurately predicts the define.xml for the datasets that would be created, based on the form design for that given EDC system.

SOME OF THE ORGANIZATIONS USING FORMEDIX

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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 content 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 MDRs, 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 MDR. 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.

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