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.
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.
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.
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities.
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.