1 SIZE FITS ALL WHEN IT COMES TO EDC BUILD

Build CRF designs in a range of EDCs. Even mix ‘n match between study phases.

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DO CRF DESIGNS FASTER, IN ANY EDC SYSTEM

Choose just about any EDC system to build your study in. Formedix integrates with all the leading ones. That means you can export your study into any of these systems. You can use different EDCs for different studies. Or even different ones for different study phases. It’s up to you!

You can even import an entire study or library from Rave or InForm into Formedix. We integrate 100% with these EDCs, so it’s just 1 click to import your data.

Want to know what your forms will look like in your EDC? Formedix shows you eCRF designs in Rave, InForm and other leading EDCs. Just click to preview. That way you can make any changes before you build your study. Once you’re ready, push a button, and BOOM – study built. Imagine how much time you could save and how much quicker you could build studies! You can see the process of how to build your EDC from standards in Formedix.

If you’re a CRO, the extra pay off is you only need to learn 1 system with Formedix. Without it, you may need to know how different EDC systems work. Including all their validation rules. That’s very time consuming, and costly for your organization. But get to grips with Formedix, and you can use any of the leading EDCs, right from our platform.

EDC SYSTEMS WE INTEGRATE WITH

What can I do with Formedix?

WHY DO CRF DESIGNS WITH FORMEDIX?

GET STARTED SUPER-FAST

If it normally takes 20 weeks to build your EDC, it can take as little as 4 with Formedix. Big bonus if you’re running lots of trials.

PREVIEW YOUR FORMS

See what CRFs look like in your EDC system – at the push of a button. No need to build. Just preview your forms anytime in Formedix.

CROs LEARN 1 SYSTEM & USE 7

Once you’re using Formedix, you can design and build client studies in any of the top EDCs. No longer spend time and resources learning 7 different systems. At the click of a button simply preview client forms, and build EDCs. Job done.

EFFORTLESS VALIDATION

Formedix validates against the rules for your relevant EDC system – even if you’re using different EDCs for study phases. No need to worry, we’ve got you covered.

CHERRY-PICK YOUR EDC - AVOID GETTING TIED IN

Choose your preferred EDC for your study. Even use a different one for each study phase. We integrate with 7 systems, including Rave, InForm and TrialMaster. This gives you huge flexibility – you’re not committed to using a specific EDC system. Mix it up, however you want.

BUILD YOUR EDC IN 1 CLICK

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

BUILD STUDIES FASTER - IMPORT CONTENT FROM EDCS

Export your study from Formedix into any of the leading EDC systems. And if you’re using Rave or InForm, you can import files from there straight into Formedix. Another benefit of our direct plug in with these 2 systems. You save so much time building to your EDC, that it takes less time to build your study.

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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, do validation checks to make sure your study doesn’t have any errors or missing metadata.

You can export your CRF into 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!

CROs CAN BE HANDS ON OR OFF 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 here about how we make building studies easier for CROs.

PHARMAS & 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, THEN CONVERT TO SDTM

You design a study using library & new content

You build EDC and convert datasets in Formedix

PREVIEW CRF DESIGNS IN YOUR EDC SYSTEM

CRFs are used to collect data from patients during clinical trials. CRF design has a direct impact on the success of clinical trial data as it helps to evaluate the effectiveness of the medical product being trialled.

A well designed CRF assists with data analysis and reporting, data management and streamlined audits. They ensure that all required data is collected, and this minimizes data queries. Poorly designed CRFs result in wasted time and resources with deadlines being missed.

Formedix understands how critical CRF design is. As a result, it has been and continues to be a major focus for us. We have worked hard to refine and optimize the form design process. A key feature is the ability to see exactly how your forms will look in your chosen EDC system – precisely at design time. So you can make any necessary changes as you go. You know exactly what you’re going to get. And, you can rest assured that importing your EDC build will be straightforward. With Formedix, you’re in control!

BUILD STUDIES FASTER IN ANY EDC

Easily design your study and build in record time with Formedix.

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.

SOME OF THE ORGANIZATIONS USING FORMEDIX

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Testimonials

EDC BUILD MADE EASY

You can easily manage your library content In Formedix. You can quickly and easily import metadata content into your study from other standards or studies.

You can save a huge amount of time and effort by reusing your metadata assets such as your forms, annotations, edit checks and terminologies which have already been standardized. You can easily and quickly move content from one location to another, and you can decide what granularity of content to import. There’s no limit to the number of libraries you can import from! As a result, your metadata content is consistent and correct and you are less likely to gather the wrong data.

We support integration with a number of different EDC’s. At the click of a button you can enable plugins that allow you to see what your forms will look like in your chosen EDC. You can carry out validation checks and have complete confidence that when you import your study into your chosen EDC, it will be seamless!

Edit checking is a critical task during the clinical trials process that verifies data entry by providing real time feedback at the point when data is entered onto a CRF. Checks are based on previously decided rules and make sure that data entered is valid, logical and correct, ensuring that the data captured is of the highest quality. Edit checks take a lot of time and resources to create, therefore it makes sense to reuse them where possible.

Not only can you validate against the CDISC ODM standard, you can also validate your EDC build, against the relevant rules for your EDC system. You can run a report which you can save or print out, or simply run our validation tool which displays error, warning and information messages. This means you can quickly and easily fix any problems as you know exactly where to look in your study.

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.

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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.

METADATA REPOSITORY & STUDY AUTOMATION TOOLS

START SAVING TIME WITH FORMEDIX

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