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Easily comply with CDISC standards

With our clinical metadata repository & clinical trial automation software platform.

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Align with CDISC. Effortlessly

Did you know the FDA is making CDISC compliance mandatory for all submissions? How does your data stack up? The good news is, Formedix can help. Our platform is built on CDISC templates – compliance is enforced from study start to finish with the latest CDISC SDTM, CDISC ADaM, and NCI standards. No expertise needed. And with automatic processes, you’ll be able to save precious time, budget and resources.

Win more trials

Our platform has CDISC compliant templates letting you build studies in both current and previous versions of CDISC. Choose the relevant version of SDTM, ADaM and SEND standards and our templates guide you every step of the way. If you make a mistake, our validator tool will alert you instantly. You can even see reports showing changes to CDISC and NCI standards. Now you’ll be in a better position to win more trials from the NIH.

Maximize resources

Formedix has automated processes to streamline studies from beginning to end. Less expertise is required for programming tasks. And you won’t need to spend money on expensive CDISC training courses. You’ll be able to make budget cuts allowing funding to stretch further than before.

Bid for more grants

Every stage in the clinical study build process is faster in our platform. Like CRF design, specifications, datasets, mappings, SDTM conversion and define.xml. And with CDISC expertise built in, you’ll save a ton of time. By saving time and resources, you’ll be much better placed to bid for more grants.

Increase chance of FDA approval

Because our platform is built on the latest CDISC standards, your study design and data automatically comply with FDA regulations. This helps to increase your chances of a successful, approved submission. And you’ll be in a better position to win more grants.

What can I do with Formedix?

Formedix metadata repository

The Formedix platform incorporates a clinical metadata repository (MDR). Think of it as a central library where all your clinical metadata is held and managed. All of your content is fully connected, from eCRFs through to submission deliverables. You can easily find, review, reuse, and share content – including across different EDC and other external systems.

With our metadata repository, you can easily manage change, whilst also complying with regulatory standards. You benefit from a structured process that adheres to regulatory compliance. And this in turn reduces associated risk.

1 home for your metadata
Different departments can access studies and organizational standards in one place. You can assign work to specific individuals, and allow parallel review by multiple specified users. This gives greater transparency and enables better communication amongst your team. Global search functionality makes it quick and easy to find studies, standards, and assets in your metadata repository.

How our MDR makes things easier
You can create and manage your organizational standards in your metadata repository. This includes importing content from your EDC system, and from your e-clinical database or other external systems. This helps to increase your data quality, and decreases downstream costs. By creating consistent forms and datasets etc. it means that building studies from scratch is now quick and easy!

For studies and standards, you can include any related links. For example, you can link to a CDISC Therapeutic Area User Guide with instructions for how to use a CRF or dataset. You can also add any related files, such as the protocol or statistical analysis plan.

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How you're better off with our clinical metadata repository

Effortlessly comply with CDISC 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. And if you’re importing existing content or legacy studies into Formedix, our CDISC validation tools flag up any issues and help you get them fixed!

Effortless validation

Validation is built in throughout Formedix from the start, so you save time and resource both during and after clinical study build. Now you can submit studies faster, as validation has been done continuously, and not left until submission at the end.

Save learning time and resources

No need to have CDISC or programming expertise. Built in standards and automated processes do all the hard work for you. This saves masses of time and you’ll need fewer resources to conduct your trials.

Save conversion time

Formedix shows what your source datasets will be, early on. Before you’ve even collected any patient data, you’ll know what your variable column headings are. That means you can get a head start on designing your SDTM datasets. And start your SDTM mappings early too. By the time you get trial data back, your datasets are all mapped, and it’s just 1 click to do your SDTM conversion in Formedix.

Have cleaner data

Because there are no worries about being CDISC compliant, your data will be of better quality. By reusing content, you’ll reduce manual errors. And, if you’re reusing content from your standardized library, it’s already been pre-approved.

No programming required

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. Like mapping specifications, metadata specifications, and define.xml. And our easy-to-use mapping tools let you create machine-readable mappings, without any coding.

Reuse content

Build your organizational standards in Formedix, and reuse them again and again. Whether it’s forms, edit checks, dataset designs, or mappings… do it once, get it approved. There’s no need to create content from scratch each time.

Share content and collaborate easily

Share content and work together from anywhere. The Formedix clinical metadata repository keeps everything in 1 place, allowing teams to work more effectively and efficiently.

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.

Save time & boost compliance by effectively managing standards & clinical metadata

Formedix makes it really easy to manage your clinical metadata. Rather than searching for standards and study content in different files and spreadsheets, easily find everything in your clinical metadata repository. All your standards are in 1 place, for all your teams to see. It’s like having a really clever library!

Need to update your standards over time? Make changes with full traceability in Formedix. Track amends and see how your study differs from your standards – in 1 place, with 1 click! And because your standards go through quality approvals in Formedix, you know that you’re consistently using approved content for your MDR clinical trials.

Probably your biggest benefit is time saved. Because everything is in 1 place. It’s easy to find, use, and reuse. There’s no need to redesign CRFs, edit checks, terminologies, and mappings for example every time. Design once and reuse content across your studies and standards – even across different EDCs.

Start building studies faster

With our automatic processes and built in compliance.

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 clinical trials, the sooner you potentially launch products  (= faster ROI).

Unlike other platforms, 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.

Clinical metadata repository & study automation tools

Frequently Asked Questions

How quickly can I get up and running with Formedix?

You can get started immediately. Our platform is off-the-shelf. Import your content and use our built in templates and validator tools to align with CDISC standards. By standardizing content, you can reuse it again and again across all your studies. That way it’s guaranteed to be higher quality and increases the chance of successful submission to the FDA.

How can Formedix help save resources?

Our platform automates many manual programming tasks that highly skilled, highly paid developers do. And because CDISC standards are built in, it means that a high level of expertise is not required. You can save training and staffing expenses, as well as a lot of time.

Which CDISC standards are required for the FDA?

The FDA is making it mandatory for clinical trials run by academic institutions to comply with CDISC SDTM, ADaM, Define-XML and SEND standards.

How long does it take to get SDTM conversions?

Our SDTM mapping tools automatically create the specifications for you. No double coding needed. That means you get your SDTM dataset conversion in as little as 4 weeks – maybe even less.

Can I use study builds in any EDC?

Yes. When you create a study build in Formedix, it’s in ODM format. All you need to do is import it into the EDC of your choice. Formedix integrates directly with 7 leading EDCs including OpenClinica. So for example, you can import content directly from OpenClinica and see how your CRFs will look and work – in Formedix. Then, make any required changes and build your OpenClinica EDC in 1 click.

What specifications can I auto-generate?

You can quickly and easily see all the specifications your teams need – in 1 click. See your CRFs as you design them in Formedix. See metadata specifications, visit structures, annotated CRFs, edit check specifications, and mapping specifications.

Start saving time & resource

With automatic processes and built in compliance.