GET A HEAD START WITH OUR CLINICAL METADATA REPOSITORY

It’s off-the-shelf, so start when you’re ready!

clinical-mdr-pharmas-reuse-manage-standards

OUR MDR & STUDY AUTOMATION PLATFORM FAST TRACKS YOUR TRIAL

Time is money when it comes to launching new products. You need to design, build and submit your study for approval ASAP so you can get products to market. Formedix fast tracks this entire process. Now you can do all those costly and time-consuming manual tasks quickly and easily with our MDR and study automation platform. You can download our flyer for more information.

START TRIALS FAR QUICKER

Have your study set up ready to start trials in record time. Upload your existing content to Formedix straightaway. And use our templates to make your SDTM datasets up front. Or if you’re outsourcing to a CRO, use our auto-generated specifications to quickly and easily make your specs.

IMPROVE STUDY QUALITY

Increase the quality of your study by reusing content from your organizational standards in Formedix. No need to retype stuff every time. So there’s no risk of manual errors, and you increase the accuracy of your study data. If you outsource to a CRO, check their work against your specs in Formedix to find any errors and increase quality.

INCREASE CHANCES OF FDA APPROVAL

The Formedix platform is built on the latest CDISC standards. So your study design and data automatically complies with FDA and PMDA regulations. This helps to increase your chances of a successful, approved submission.

MAXIMIZE PROFITS

Quicker EDC launch and faster SDTM data visibility ensures higher quality studies, and gets you to submission faster. And the sooner you get FDA approval, the faster you can bring products to market – with the same or fewer resources! That means scope to run more trials and launch more products over time.

What can I do with Formedix?

WHAT'S IN IT FOR ME?

START YOUR STUDY PRONTO

Instantly bring your library of forms, datasets or legacy forms into Formedix. Then crack on with EDC design & build. Or get your CRO straight on it. If it typically takes 20 weeks for you to set up a study without Formedix, it can take as little as 4 weeks with Formedix. That’s a huge time saving.

PREVIEW STUFF FIRST

See what CRF designs, datasets, and mappings will look like before you start your trial. All at the push of a button. You choose the format – Excel, Word, PDF… Make any changes. Preview again, and repeat until you’re happy!

GET YOUR DATASETS MUCH FASTER

It generally takes around 8 weeks to get your SDTM datasets. Not ideal. You need to see your trial data ASAP. Formedix can give you SDTM conversions in as little as 4 weeks – usually less.

EASILY MAKE CHANGES MID STUDY

Your source and SDTM datasets are ready and mapped upfront, before the trial. So it’s easy to make amends during your study without causing delays in the process. Make changes, then refresh your data to see what it looks like now. Simple!

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.

REUSE CONTENT

Build your organizational standards in Formedix, and reuse this content forever more. Whether it’s forms, edit checks, dataset designs or mappings… do it once, get it approved, and there’s no retyping.

CHOOSE YOUR EDC & BUILD FASTER

Choose just about any EDC to build your study in (we’ve got plug-ins for 7). Even use different EDCs for different study phases. Timescales? You can expect to wait around 20 weeks for your EDC build without Formedix. With Formedix, you’re looking at around 4 weeks.

SAVE CONVERSION TIME

Formedix shows what your source datasets will be, really early on. Way before you’ve collected any patient data, you’ll know your variables (column headings). Based on this, you can design your SDTM datasets. And that means you can do your SDTM mappings early too. By the time you get trial data back, your datasets are all mapped, and it’s just 1 click in Formedix to do your SDTM conversion.

MORE CONSISTENT DATA

Reusing content – rather than typing it out each time – cuts out mistakes and human error. And because it comes from your internal standards, you’re using pre-approved, consistent content across clinical studies.

0

instead of 1,484 EDC labor hours

0

instead of 486 SDTM labor hours

0

weeks instead of 20 for EDC go-live

0

weeks instead of 8 to see SDTM data

WHAT IS A CLINICAL METADATA REPOSITORY?

Formedix clinical trial automation software 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 clinical 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 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.

GET QUALITY FROM YOUR CRO

Working with a CRO? You can automatically make specifications in Formedix to pass over to them. Once you get datasets back from the CRO, you can validate them against your specs for accuracy and regulatory compliance.

WANT TO MAKE CHANGES MID STUDY?

With Formedix, you have your SDTM datasets all done and mapped before the trial starts. So if you make changes mid study, just refresh your datasets to see what they look like with your changes.

HOW OUR CLINICAL TRIAL AUTOMATION SOFTWARE IS 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 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.