GET A HEAD START WITH OUR CLINICAL METADATA REPOSITORY
It’s off-the-shelf, so start when you’re ready!
OUR CLINICAL METADATA REPOSITORY & 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 clinical metadata repository 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?
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.
SOME OF THE ORGANIZATIONS USING FORMEDIX
Testimonials
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities. ...
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.
CLINICAL METADATA REPOSITORY & STUDY AUTOMATION TOOLS
Frequently Asked Questions
How quick is it to get started using Formedix?
You can get started with Formedix straight away. Start by importing your content. Use the built in templates to create your SDTM datasets, or auto-generate specifications to give to your CRO. Reusing standardized content means your study will be better quality. If you outsource, you can check work against specifications generated in Formedix. Built in CDISC standards, means successful regulatory submissions. You can get products to the market faster and maximize your profits.
How easy is it to make mid study changes?
Very easy! You can create your SDTM datasets and get them mapped before the clinical trial starts. If you need to make changes mid study, all you need to do is refresh your datasets. Then, you can see what your changes look like.
How can Formedix help with regulatory compliance?
With Formedix it’s easy to automatically create specifications. If you’re working with a CRO, you can validate the datasets you get back from them against your specifications for accuracy and regulatory compliance. Formedix is built on the latest CDISC compliant templates, so you’ll also you automatically comply with the latest FDA and NCI standards.
How quickly can I get datasets using Formedix?
You can get your SDTM conversion in as little as 4 weeks – often in even less time than that!
How does Formedix help with consistent data?
By allowing you to reuse your standardized content. This removes the possibility of human error. Your content has already been approved – so that means you’ll have consistency across all your organizational standards and studies.
What previews will I be able to see?
You can see what your CRF designs, datasets, and mappings will look like before you start your trial. Simply choose what format you want, for example Excel, Word, PDF.
Formedix is an all-in-one fully integrated platform to design and build your clinical trial – without any coding knowledge.
Made for pharmas, biotechs and CROs, the Formedix metadata repository and clinical trial automation software makes it quick and easy to find, manage, reuse and share your metadata. The result? You can design, build and submit your trials much faster than before.
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