With the help of our clinical trial automation software.
There’s a lot of labor intensive processes involved before you have your nice datasets. There’s manual mappings to do. Converting datasets. Getting your Define. Publishing PDFs. It all takes time. Formedix does all these, and more. So you get your datasets and metadata, quicker, with less effort. Download our flyer for more information.
Have your standardized data all ready to start analysis much quicker with Formedix. Our automated conversion processes and built in CDISC templates speed up the end-to-end clinical trial process, so you can get on with data analysis much sooner.
Not only can you rest easy that your data complies with CDISC, you can be sure of greater quality too. Reusing content cuts down on manual errors. And if you’re reusing content from your organizational standards, it’s all pre-approved.
Formedix automates many of the manual, labor intensive dataset conversion jobs. There’s no need to figure out your source dataset variables (column headings). Or manually do your mappings and double code data conversions. You get these automatically in Formedix, so you save loads of time.
Stay on top of new and emerging CDISC standards. Our metadata management tools are built on CDISC foundations. We keep up-to-date with new metadata standards – such as ARM – so that you can work with these too.
The Formedix platform 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 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.
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.
Formedix lets you predict the structure of raw datasets so you can see how your data looks in your chosen EDC. You can start your SDTM mappings early on. And, you can see patient data as soon as it’s in you EDC. Once your mappings are done, it’s 1 click to do your SDTM conversion. That’s a huge reduction in lag time!
Formedix has compliance build in so you’re always aligned with SDTM and ADaM standards. We keep up to date with the latest CDISC standards and support older versions. Our validation tool monitors the quality of specifications, mappings and datasets. It highlights any errors, and tells you where to fix them. You’ll have quality deliverables and your submission will stand up to scrutiny of FDA regulators.
You’ll no longer need to manage and maintain standards manually. CDISC standards are built in and updated so you’ll always conform to FDA regulations. You can instantly see granular difference reports showing every change to controlled terminology and CDISC standards. Plus, any changes made to standards and studies.
All your standardized content is stored in 1 place. That includes mappings, terminologies, SDTM and ADaM datasets, specifications, and other metadata. Because everything’s standardized, there’s no need for manual creation from scratch. You’ll get around 80% reuse of your standards! That’s a huge time saving. Your standardized content will be consistent, and comply with FDA regulations.
Formedix lets you map your source datasets from your EDC system to SDTM datasets, and from ADaM datasets back to SDTM, easily. Plus, you can see what your EDC datasets will look like early on. This lets you define your mappings earlier.
You can build, preview, and validate studies for 7 leading EDC systems. They are Medidata Rave, Oracle InForm, XClinical Marvin, OmniComm TrialMaster, OpenClinica, Parexel DataLabs, and Mi-Co Mi-Forms. All you have to do is pick which EDC you want to use in a particular study phase. You can use different EDCs for different phases in your study. You’re not tied to just 1 EDC at any time!