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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 automation repository 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 automated metadata management, 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 metadata automation – in other words speeding up and simplifying processes. Our clinical study software can help by automating lots of things in the build process – 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 metadata management automation platform can give the boost you need. See below for all the parts of study design and build we can help with.
Formedix is one of the leading clinical trial software companies. Our platform incorporates a clinical metadata repository (MDR) for metadata automation. 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 automation 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 make automation in clinical trials 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. 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.
We are using the Formedix platform to design CDASH-compliant, example CRFs for the CDISC eCRF Portal. 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, 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.