1 CLICK SDTM CONVERSION

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

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CREATE SDTM DATASETS, FAST.

SDTM and ADaM datasets are essential in your submission for drugs and product approval. And if you don’t get datasets done early on, it can cause delays in future. You even risk not collecting the exact data that’s needed for the trial.

As it stands, your source datasets (from your library or EDC) need a lot of work to get them into SDTM datasets. That takes time and programming skills = money.

SDTM conversion is quick and easy in Formedix. There’s no coding, and we use templates to speed things up. Our SDTM mapping tools help you match the variables in SDTM with the relevant variables in your source datasets. Forget trying to work out what your source dataset headings will be. Once you’re done, press a button for your SDTM datasets and SDTM define.xml files.

What can I do with formedix?

MAKE COMPLIANT SDTM & ADaM DATASETS

Use our clinical trial automation software to make SDTM datasets upfront. You can even create them before you’ve collected any patient data. That way, you get SDTM conversion done early on, and can check that your datasets will meet regulatory requirements. You also get a head start on mapping your ADaM datasets back to SDTM.

Easily design datasets

Templates let you add domains and variables that are compliant with the relevant versions of CDISC standards. Tailor them to your needs by adding additional metadata – such as supplemental qualifiers, derivation methods and value list metadata. Our clinical metadata management tools help ensure that your datasets comply with CDISC Define-XML, CDASH, SEND, SDTM and ADaM standards.

Create standards for reuse

You can arrange your datasets into organizational standards for reuse in future. This increases data quality and saves so much time and resources.

Easily manage CRO specs

Use Formedix to make specifications if you’ve got a CRO designing datasets for you. When you get datasets back, simply check them against your original specs to ensure they’re as you expected.

What will my datasets look like?

See how your SDTM datasets will look to regulators reviewing your submission. Either PDF or HTML format. This includes links to pages in external documents, like Annotated CRFs.

SDTM CONVERSION MADE EASY

PREVIEW DATASETS

Push a button for SDTM conversion and easily see how your datasets will look to reviewers. Preview in PDF or HTML format, and make any changes until you’re happy.

EASILY DO CDISC SDTM MAPPING

Our SDTM mapping tools make the job of creating and describing your SDTM mappings much easier. Whether it’s simple or complex mappings, Formedix has a user friendly framework for you.

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.

IMPROVE CONSISTENCY

Reusing datasets and mappings helps to keep consistency across studies and standards. This content has already been approved, so you can use it consistently in future.

QUICKLY CREATE DATASETS

Rather than struggling to figure out your source dataset column headings (variables), Formedix helps you do this. You’ll get to see what your source datasets will be really early on – well before you’ve collected any patient data.

AUTOMATICALLY CONVERT DATASETS TO SDTM

Once Formedix has shown what your source dataset column headings will be, you can design your SDTM datasets. And because you get this way before you’ve collected any patient data, you can do your SDTM mappings early on too. By the time you get trial data back, your datasets are all mapped, and it’s just 1 click in Formedix for SDTM conversion.

NO PROGRAMMING NEEDED - SAVE COSTS

No need for any programming knowledge. And you don’t need programmers to ‘double program’ data conversions from your specifications. Our easy-to-use mapping language lets you create machine-readable mappings, without any coding. As a result, you save both time and resource costs. 

EDC SYSTEMS WE INTEGRATE WITH

EFFORTLESS CDISC COMPLIANCE

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

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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. Click below to find out more.

CROS CAN WORK FLEXIBLY WITH CLIENTS

The Formedix platform lets CROs work with clients in different ways. You can manage the whole process from design to submission. Or, you can just help with specific tasks if that’s what the client wants. You can be flexible in other ways too. Let clients only see study designs. Or let them work with you and create new content. See more about how Formedix helps CROs with SDTM conversions and more.

PHARMAS AND BIOTECHS CAN WORK IN-HOUSE OR OUTSOURCE

Whether you’re doing it yourself, or outsourcing to a CRO, Formedix accommodates how you want to work.

CRO DESIGNS & BUILDS FOR YOU

Share your standards library with CRO

CRO designs your study based on standards

CRO builds your EDC and converts to SDTM

YOU DESIGN, CRO BUILDS FOR YOU

You design a study using library & new content

CRO builds your EDC and converts to SDTM

YOU DESIGN, BUILD & CONVERT

You design a study using library & new content

You build EDC and convert datasets in Formedix

SDTM MAPPING TOOLS

Your study can also manage other metadata in Formedix, such as SDTM mappings. These describe how the original (or source) datasets from your EDC system map to the CDISC SDTM standard. See an example of a mapping specification. Our CDISC SDTM mapping tools let you make and validate simple variable to variable mappings, as well as more complex mappings with many steps.

Upfront mappings

Mapping data upfront helps ensure that all the relevant data is collected. Formedix clinical trial automation software shows what your EDC datasets will look like – before you get them. So you can do your mappings early on. Then crack on making your SDTM define.xml files once your first EDC datasets are ready.

And if you include SDTM mappings in your organizational standards, you can easily re-use them. That means faster study designs, and better quality data.

Human-readable mappings

In Formedix, you make human-readable mappings that clearly describe how datasets and variables in your original (source) datasets map to their equivalents in SDTM. From there you can create a metadata specification for programmers.

Machine-readable mappings

You can also create machine-readable mappings with our easy-to-use mapping language in Formedix. No programming knowledge is needed. Once your mappings are done and approved, use them to turn your source datasets into SDTM datasets (using our templates). You’ll save time and money as there’s no need for programmers to double program data conversions from your specifications. Reports give you full traceability of all mappings to ensure data is accurately mapped.

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instead of 1,484 EDC labor hours

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instead of 486 SDTM labor hours

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weeks instead of 20 for EDC go-live

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weeks instead of 8 to see SDTM data

HOW TO BUILD STUDIES FROM STANDARDS

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You can quickly and easily build a study from a set of standards. First, create and approve your organizational standards in line with your internal processes.

Select your forms and related datasets from your standards. All related metadata, such as edit checks and mappings, is brought in automatically with your standards. Add any relevant protocol information – such as the visit schedule, custom edit checks, or custom mappings.

Then use our visualization tool to see what your CRFs look like in your chosen EDC system.

Once you’re done, you can carry out validation checks to make sure your study doesn’t have any errors, or is missing any metadata.

You can export it to your chosen EDC system, confident that it will work – you know the study is exactly as you designed! You can also create your source Define.xml and ensure that it meets the various regulatory requirements to help you achieve hassle free submission. Mappings are part of the study design, so you can generate initial downstream datasets. That means you don’t need to program the data conversion for your study!

MAKE YOUR DATASETS SUPER FAST

DATASET CONVERSION

SDTM conversion is when you turn your original (source) datasets into SDTM datasets. This is done using the SDTM mappings and templates in Formedix. You can do this at various stages, from study start to submission. SDTM dataset creation during the clinical trial lets you check your data integrity – as soon as data becomes available.

We can automatically upload your original source data into Formedix – whether it’s in SAS Transport v5 (.xpt), dataset-XML or CSV formats. Or you can manually upload data, for example, from legacy studies.

Data transformation is simple too. Your data is already mapped at study design. So you can run conversions automatically as soon as your trial data comes in. Not only that, you can automatically download the data in SAS Transport v5 (.xpt), dataset-XML and CSV formats. Our SDTM validation tools ensure that datasets conform to the relevant CDISC standards.

SOME OF THE ORGANIZATIONS USING FORMEDIX

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Testimonials

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 can get products to market (= 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 meta data 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.

METADATA REPOSITORY & STUDY AUTOMATION TOOLS

TELL US ABOUT YOUR PROJECT

Tell us what’s giving you grief, and we’ll show you how we can help.