MANAGE CONTENT IN 1 CENTRAL PLACE

With our off-the-shelf metadata repository (MDR).

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THE EASIEST WAY TO STORE, REUSE & APPROVE YOUR STANDARDS & STUDIES

Imagine if all your study content – standards, forms, datasets, mappings… everything, was in 1 place. And they were all interconnected. Everything from eCRFs to submission deliverables. No matter where they were, your teams could share and reuse content, approve standards and studies – even across different EDCs and e-clinical systems. That’s Formedix. The all-in-1 fully integrated metadata repository. And you can start now, it’s straight out the box ready to go.

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BUILD STUDIES FASTER

Building studies from scratch is far quicker and easier with our MDR. You’ve got pre-approved, consistent content in your metadata repository, which can be reused forever more in studies and standards. Instead of starting out with nothing, you’ve got an entire library of content ready to go!

SAVE TIME & WORK TOGETHER

Because all your content is in 1 place, you don’t need to go hunting for it. Everything held in your studies and standards is right there for all to see. Different teams can get at the data they really need, and easily share and approve content. Plus, you save acres of time reusing content – rather than typing it out by hand.

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IMPROVE STUDY QUALITY

Increase the quality of studies by reusing content from your standards library in our metadata repository. You’re not retyping this content, so there’s no manual errors. And because you’re using standardized content, you know it’s already been approved internally.

REDUCE COSTS

By building your standards and study library in Formedix, you cut study build costs. You get started so much faster because the majority of your content is already there in your metadata repository. And if the data you want isn’t there, just import it into your Formedix library from your EDC or internal systems.

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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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WHAT'S IN IT FOR ME?

FIND THINGS QUICKLY

With all your content in 1 place, it’s easy to find what you’re looking for. You no longer need to hunt through lots of different documents, stored in lots of different places. Quickly search across all your standards and studies in Formedix.

PREVIEW STUFF FIRST

You can preview assets in many formats, including HTML, PDF and Excel. For example, see what a form looks like in your EDC system before it’s built. Then easily make changes and keep previewing until it’s right. This dramatically speeds up EDC build, and helps you get things right much earlier in the process.

WORK DIRECTLY IN YOUR EDC

Automatically work in your EDC, without ever leaving Formedix. That’s because we integrate with the leading EDCs, including Rave and InForm.

DECIDE YOUR LIFECYCLE STAGES

You’re in control. You decide what lifecycle stages you want in your standards and studies. It all depends what makes sense for your company. Alternatively, just use the default lifecycle in Formedix that’s ready to use.

REUSE CONTENT

Reuse content in your Formedix metadata repository across standards and studies. You can easily import standardized content from your EDC or e-clinical database. In other words, automatically upload forms, datasets, mappings, edit checks, terminologies etc into Formedix to store and reuse. This saves lots of time, and because you’re using pre-approved content, you know it’s correct.

KEEP TRACK OF CHANGES

Easily see a full and detailed lifecycle history of a standard. If you need to know something about a particular standard, the answers are all recorded in your metadata repository. That way you have complete transparency between team members. And you avoid regulatory non-compliance.

SYNC WITH FORMEDIX

Our API lets your system automatically communicate with our metadata repository. No logging in to the Formedix platform and manually uploading data. Instead, you can have a direct route in to automatically upload and download datasets from your standards and studies. This saves time and means you can set up automatic processes, for example to synchronise 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 standards within a company defined governance workflow. You have complete control over your study designs.

Choose your forms and related datasets from your standards. All related metadata, such as edit checks and mappings, is brought in automatically with your standards, so you know they’re correct.

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 does not contain 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 generate your source Define.xml and ensure it meets the various regulatory requirements to help you achieve a hassle free submission. Mappings are part of the study design so you can generate initial downstream datasets – you don’t need to program the data conversion for your study!

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

NEED OUR METADATA REPOSITORY TO BE CUSTOMISED FOR YOU?

An off-the-shelf solution doesn’t always meet your needs. No problem. Our in-house development team has had a lot of practice at this. We can customise our platform to work for you. Best to get in touch and tell us all about it.

WHAT CAN FORMEDIX DO FOR ME?

We help pharmaceutical and life sciences teams work more collaboratively and get more done. And by getting rid of long manual processes, and building in compliance, we make life just that bit easier!

WHY USE AN MDR?

The pharmaceutical industry has been changing over the last 10 to 20 years. Things are moving from paper based clinical trials, to electronic data capture based clinical trials. There’s also a larger number of sponsors, trials and data than ever before to deal with. Industry standards have become an absolute necessity for governing and managing clinical trials. These are now required as part of the submission to regulatory bodies, such as the FDA.

As a result, clinical trials are facing increasing challenges, and spiralling costs. A clinical metadata repository (or MDR for short) helps to address these challenges. Having a centralized web platform for managing clinical trial metadata saves time and reduces manual labour. This ultimately helps reduce the cost of setting up and managing clinical studies.

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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

Controlling Change

Change during the clinical trial process is a painful, unavoidable reality. It it also essential for quality assurance. And we all know that change control that isn’t properly managed results in regulatory non-compliance.

Formedix takes away all that pain and allows you to manage changes confidently, knowing that nothing has been missed. Change request details are easy to find and review in Formedix. You can even download a summary of all change requests.

We give you complete flexibility. You can even customise your own change request templates – each with their own workflow – which you can configure to suit your needs.

Impact analysis tools in Formedix help you clearly see the impact of any proposed changes.  You can also  identify any associated assets that may need to be updated.

You can run reports that show the differences between your studies and organizational standards. And you can compare a study to your standards, or other studies, or previous versions. That way you have complete control over change.

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.

Collaboration

Everyone knows that people achieve more working together in teams than they do alone. Our metadata repository gives you total transparency throughout the end to end process which helps to improve the quality of your clinical trial data.

Formedix allows you to set up role-based access to standards and studies. Standards can be available to all, or locked down to specific teams. Studies can be open to all, or restricted to a smaller study team Individual teams can have different access, e.g. Data Managers may be able to edit forms and view datasets and Biostatisticians may be able to view forms and edit datasets and mappings.

METADATA REPOSITORY & STUDY AUTOMATION TOOLS

EVERYTHING YOU NEED IN 1 PLACE

Design, build and manage your metadata. All in 1 place.