DESIGN, BUILD & MANAGE STUDIES IN 1 CENTRAL PLACE

With our off-the-shelf metadata repository & study automation platform.

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Clinical Metadata Repository

If you’re looking to manage clinical data standards and study metadata, you’re in the right place! Our clinical metadata repository (MDR) provides a central home for your organizational standards. Here you can manage and update your standards – while keeping on track with the latest CDISC standards, and complying with regulatory requirements. And if you need help with study automation, we can do that too. Our study automation tools use the content in your MDR to help you design and build your studies much quicker and easier. Find out more HERE.

Study Automation

Perhaps for you it’s less about storing and managing your metadata. It’s more about speeding up and simplifying processes. If so, we can automate lots of things in the clinical study cycle – from study start up to analysis. Maybe building your EDC takes far too long. Or you’re finding SDTM dataset creation a chore. If so, our study automation tools can give the boost you need. See below for all the parts of a study we can help with.

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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METADATA REPOSITORY & STUDY AUTOMATION TOOLS

What can I do with Formedix

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.

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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

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 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.

SOME OF THE ORGANIZATIONS USING FORMEDIX

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Testimonials

VALUES THAT DRIVE US

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PASSION

We love what we do, love our community, and seeing the difference we make for people in the industry.

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INNOVATION

We’re always adding new stuff – mostly from your feedback. And our product road map promises lots more features to come.

INTEGRITY

You need us to be honest and clear, and that’s exactly how we are. We do what we say, and if we can’t do something, we’ll tell you.

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COLLABORATION

We genuinely care about you succeeding, and we’re on your side – think of us as an extension of your team.

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ADDED VALUE

We get on with things and get them done, no messing. And we’re fast, so you get more done, faster, and get a quick ROI.

GOT A PROJECT IN MIND?

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