With our off-the-shelf clinical metadata repository & clinical trial automation software.
If you’re looking to manage clinical metadata and data standards, you’re in the right place! Our clinical metadata repository (MDR) provides a central home for your organizational standards. Here you can manage and update your standards – while keeping on track with the latest CDISC standards, and complying with regulatory requirements. And if you need help with study automation, we can do that too. Our clinical trial building and automation software uses the content in your clinical metadata repository to help design and build your studies much faster. Find out more about our clinical metadata repository.
Perhaps for you it’s less about storing and managing clinical metadata. It’s more about speeding up and simplifying processes. If so, we can automate lots of things in the clinical study build cycle – from study start up to analysis. Maybe annotated CRFs are too laborious. Or building your EDC study takes too long. Finding SDTM datasets a headache? Define.xml files holding up submissions? If so, our clinical trial building and automation software can give the boost you need. See below for all the parts of study design and build we can help with.
The Formedix platform incorporates a clinical metadata repository (MDR). Think of it as a central library where all your clinical metadata is held and managed. All of your content is fully connected, from eCRFs through to submission deliverables. You can easily find, review, reuse, and share content – including across different EDC and other external systems.
With our clinical metadata repository tools, you can easily manage change, whilst also complying with regulatory standards. You benefit from a structured process that adheres to regulatory compliance. And this in turn reduces associated risk.
1 home for your metadata
Different departments can access studies and organizational standards in one place. You can assign work to specific individuals, and allow parallel review by multiple specified users. This gives greater transparency and enables better communication amongst your team. Global search functionality makes it quick and easy to find studies, standards, and assets in your metadata repository.
How our Clinical Metadata Repository tools makes things easier
You can create and manage organizational standards in your clinical metadata repository. This includes importing content from your EDC system, and from e-clinical or other external databases. This helps to increase your data quality, and decreases downstream costs. By creating consistent forms and datasets etc. it means that building studies from scratch is now quick and easy!
For studies and standards, you can include any related links. For example, you can link to a CDISC Therapeutic Area User Guide with instructions for how to use a CRF or dataset. You can also add any related files, such as the protocol or statistical analysis plan.
Formedix has been a valuable resource and their services have added value to our platform and data management capabilities. ...
We love what we do, love our community, and seeing the difference we make for people in the industry.
We’re always adding new stuff – mostly from your feedback. And our product road map promises lots more features to come.
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.
We genuinely care about you succeeding, and we’re on your side – think of us as an extension of your team.
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.
Yes, it’s quick and easy to get started. All you need to do is import your existing studies and standards. Then, you’ll have a library of content that’s easy to find, reuse, edit and share.
We have a professional services team in place to help and support you at all times. They are experts in their field, and if there’s something you need done, we can help. Just let us know what it is.
Aside from storing and managing clinical trial metadata, it speeds up and simplifies processes. These processes are built in from study startup to analysis. That means you can get your regulatory compliant clinical study submitted much faster, with less manual effort.
By using organizational standards, it’s much quicker to build your study. Having all your content in 1 place and being able to reuse it saves lots of time. It also means your teams can collaborate effectively. The quality of you studies will be improved and you’ll save money by reducing study build costs. Find out more about the Formedix clinical metadata repository.
Yes. Formedix uses templates that are built on the latest CDISC standards, so you’ll automatically comply with the latest FDA and NCI standards.
Yes. Formedix integrates with CDISC ODM, Define-XML, ARM and Dataset-XML file format standards. CDISC SDTM, ADaM and SEND content standards. CDISC Share, SAS Transport v5 (XPT), PDF, Excel, HTML and 7 different EDCs including Rave and InForm.