BUILD CLINICAL TRIALS FASTER

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

SDTM-dataset-creation-define-xml-EDC-studies

SLASH CLINICAL STUDY BUILD & EDC SET UP TIME

Spreadsheets and manual tasks giving you grief? It’s understandable. You’re dealing with a mountain of files, and faced with lots of time-consuming jobs. There’s EDCs forms, database and edit check specs, and annotated CRFs to name a few. It all impacts on study specification and build time. But with a little help from Formedix – and a lot of automation – this can all change…

SAVE TIME ON EDC DESIGN

Get your EDC design approved in around 1/4 of the time it normally takes. Instantly see eCRFs designs for your chosen EDC system – without even having that EDC system installed! Our preview tool instantly visualizes your eCRF in Formedix. This speeds up the approval process, with typically less review cycles, and less time taken over design review.

REUSE CONTENT ACROSS MANY EDCS

You can ruse content across lots of different platforms – including across many EDCs. Design content in Formedix – or import it from Rave or InForm – then reuse it anywhere. So you’re not locked in to just using a specific EDC system. Formedix lets you be flexible and reuse content – even when you’re working with different EDCs.

IMPORT CONTENT & BUILD STUDIES FASTER

You can instantly import CRF designs from your existing EDC system into Formedix. For example, import legacy studies from Rave or InForm EDCs and reuse where you like. This really helps you build studies much faster.

COMPLY WITH MULTIPLE EDC SYSTEMS

Formedix clinical trial automation software validates against CDISC standards. Not only that, it validates against the particular EDC system you’re using. You don’t need to know the specific rules of your EDC. Formedix takes care of that for you with built in EDC validations tools.

What can I do with Formedix?

WHAT'S IN IT FOR ME?

DESIGN IN 7 EDCS & IMPORT CONTENT

Pick just about any EDC system to work with. Formedix integrates with the top 7. That means you can export content to all of these, do edit checks, and preview eCRFs – without even leaving Formedix. You can even switch between EDCs for different study phases. And you can import files from Rave and InForm.

EFFORTLESSLY COMPLY WITH 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.

EASILY KEEP TRACK OF CHANGES

There’s full traceability in Formedix. You can see where a standard is used in studies, and any changes made to that standard over time. You can also see how your study differs from your standard in 1 click.

BUILD YOUR EDC IN 1 CLICK

Happy with your forms? Now it’s 1 click to build you EDC. Formedix automates the build process, saving tons of time, so you can start your trials much sooner.

SAVE TIME BY REUSING CONTENT

Reuse content from one study to another study – even across multiple EDCs. Reuse forms, standards, terminologies, edit checks… No need to re-type stuff, so you save loads of time.

EASILY SHARE CONTENT AND COLLABORATE

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.

WHAT IS A CLINICAL METADATA REPOSITORY?

The Formedix clinical trial automation platform incorporates a clinical metadata repository (MDR) – a single source of truth! Its core features help to optimize the clinical trial process, and bring life-saving products to market, faster.

Your whole team can access all your standards and studies in one place, on the web. The metadata repository allows you to do lots of different things. For example, you can control access, assign work to individuals, allow parallel review, perform impact analysis, and version all of your content.

Global search functionality makes it quick and easy to find studies, standards, and assets in your clinical metadata repository. This gives greater transparency, control and better communication amongst your team. In doing so, you produce higher quality study designs, which gives you more consistent data for your submissions.

CLINICAL METADATA REPOSITORY & STUDY AUTOMATION TOOLS

API

CRF DESIGN & EDC DESIGN

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SDTM & ADAM DATASETS & SDTM CONVERSION

VISUAL DEFINE.XML EDITOR

ANNOTATED CRFS

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VALIDATION

START BUILDING STUDIES FASTER

With our automatic processes and built in compliance.

SOME OF THE ORGANIZATIONS USING FORMEDIX

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).

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 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.

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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

VALUES THAT DRIVE US

PASSION

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

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.

COLLABORATION

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

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.

Frequently Asked Questions

Can I reuse my standardized content in Formedix?

Yes. All your standardized content is stored in 1 place. You can upload existing content from your EDC or internal system. You can set up your organizational standards and manage them through the lifecycle process. It’ll take a fraction of the time it used to take to get your studies completed. And, your content will be consistent and be higher quality. You can find out more about designing eCRFs and EDCs.

Is it easy to find metadata content?

Yes. Because all your assets, standards and studies are stored in 1 place, it’s quick and easy to find what you’re looking for. You don’t need to go hunting for content, or rely on others to provide it. You can instantly find it, view it, and re-use it, again and again. Saving lots of time!

What are the different views of data my team can see?

It’s quick and easy to see all the different metadata formats you need in visualizations. You can see what CRFs look like in your EDC as you design them. You can see metadata specifications, visit structures, edit check specifications, mapping specifications, submission ready annotated CRFs in PDF format, SAS XPT, and SAS v9 clinical views.

How does change management work in Formedix?

You can easily see, track and manage changes in Formedix clinical trial software. There’s full transparency and traceability between teams. Version control makes it easy to track changes to your content. Difference reports show the differences between versions of content. It’s easy to see the when, why, what and who behind a study specific change which helps refine your next EDC study design. And you can save time on your next study because you only need to review updated content!

Can I set my own workflow for approvals?

Yes. We do have a built in approvals process as default, but you can set your own to whatever suits your organization. Team members can review, collaborate and improve content in a controlled and efficient way. Everything’s recorded for all to see. Once content has been agreed and approved, it becomes standardized content ready to use again and again.

Can I use different EDCs for different phases of a study?

Yes. Just pick which EDC you want to use in a particular phase. You are not tied to just 1 EDC at any time. Our validation tool lets you build, preview and validate studies for 7 leading EDC systems, including Rave and InForm. And, it’s easy to see where to go to fix any errors.

EVERYTHING YOU NEED IN 1 PLACE

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

MDR

Study Automation

Formedix For…

Professional Services

Training

MDR