It’s off-the-shelf, so start when you’re ready!
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.
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.
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.
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.
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.
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.
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!
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.
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!
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.
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 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.
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.
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.
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.
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.
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 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.
We’re using the Formedix platform to design CDASH example CRFs for the CDISC CDASH-IG standards package. We can create, visualize, edit and approve eCRFs in the platform, then export them in ODM-XML to use in the CDISC Library and standards packages. Formedix is one of CDISC’s longest standing members. CDISC is keen to work with technology partners that help pharmaceutical organizations to adopt and keep pace with emerging CDISC standards.
Peter Van ReuselCDISC Chief Standards Officer
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities.
Carlos VasquezScience 37
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.
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.
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.
You can get your SDTM conversion in as little as 4 weeks – often in even less time than that!
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.
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.
The Formedix metadata repository and clinical trial automation platform will help you design, build, and submit your trials much faster than before.
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