With our clinical metadata repository & clinical trial automation software platform.
Spreadsheets and manual tasks giving you grief? It’s understandable. You’re dealing with a mountain of files, and faced with lots of time-consuming jobs. There’s EDCs forms, database and edit check specs, and annotated CRFs to name a few. It all impacts on study specification and build time. But with a little help from Formedix – and a lot of automation – this can all change…
Get your EDC design approved in around 1/4 of the time it normally takes. Instantly see eCRFs designs for your chosen EDC system – without even having that EDC system installed! Our preview tool instantly visualizes your eCRF in Formedix. This speeds up the approval process, with typically less review cycles, and less time taken over design review.
You can ruse content across lots of different platforms – including across many EDCs. Design content in Formedix – or import it from Rave or InForm – then reuse it anywhere. So you’re not locked in to just using a specific EDC system. Formedix lets you be flexible and reuse content – even when you’re working with different EDCs.
You can instantly import CRF designs from your existing EDC system into Formedix. For example, import legacy studies from Rave or InForm EDCs and reuse where you like. This really helps you build studies much faster.
Formedix clinical trial automation software validates against CDISC standards. Not only that, it validates against the particular EDC system you’re using. You don’t need to know the specific rules of your EDC. Formedix takes care of that for you with built in EDC validations tools.
The Formedix clinical trial automation 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 clinical 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.
Yes. All your standardized content is stored in 1 place. You can upload existing content from your EDC or internal system. You can set up your organizational standards and manage them through the lifecycle process. It’ll take a fraction of the time it used to take to get your studies completed. And, your content will be consistent and be higher quality. You can find out more about designing eCRFs and EDCs.
Yes. Because all your assets, standards and studies are stored in 1 place, it’s quick and easy to find what you’re looking for. You don’t need to go hunting for content, or rely on others to provide it. You can instantly find it, view it, and re-use it, again and again. Saving lots of time!
It’s quick and easy to see all the different metadata formats you need in visualizations. You can see what CRFs look like in your EDC as you design them. You can see metadata specifications, visit structures, edit check specifications, mapping specifications, submission ready annotated CRFs in PDF format, SAS XPT, and SAS v9 clinical views.
You can easily see, track and manage changes in Formedix clinical trial software. There’s full transparency and traceability between teams. Version control makes it easy to track changes to your content. Difference reports show the differences between versions of content. It’s easy to see the when, why, what and who behind a study specific change which helps refine your next EDC study design. And you can save time on your next study because you only need to review updated content!
Yes. We do have a built in approvals process as default, but you can set your own to whatever suits your organization. Team members can review, collaborate and improve content in a controlled and efficient way. Everything’s recorded for all to see. Once content has been agreed and approved, it becomes standardized content ready to use again and again.
Yes. Just pick which EDC you want to use in a particular phase. You are not tied to just 1 EDC at any time. Our validation tool lets you build, preview and validate studies for 7 leading EDC systems, including Rave and InForm. And, it’s easy to see where to go to fix any errors.