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Design & build studies faster - in 1 central place

Clinical Metadata Management

With our off-the-shelf clinical metadata repository & clinical trial automation software.

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Clinical metadata repository (MDR)

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.

Clinical trial automation

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 metadata repository

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.

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Clinical metadata repository & study automation tools

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CRF design & EDC build
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SDTM Datasets, SDTM Mapping & SDTM Automation
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Visual define.xml editor
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instant-annotated-crfs
Annotated CRFs
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validate-cdisc_sdtm_clinical_study_build
Validation
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clinical_trial_edc_build
API
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What can I do with Formedix

Effortless CDISC compliance

We manage your CDISC compliance. So you don’t have to.

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Don’t worry about meeting the latest FDA data standards. Formedix supports all versions of CDISC standards. And we keep our platform updated in line with CDISC and NCI standards. That way your study designs and datasets are always regulatory compliant.

As one of the first CDISC members back in 2001, you can rely on our deep rooted knowledge of all things CDISC. We’re members of the CDISC Data Exchange Standards team. As such we’ve been involved in developing many key features in CDISC ODM and Define models. This makes us well placed to give real-world, practical CDISC training. See our CDISC membership certificate for the year 2020-2021. Click below to find out more.

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instead of 1,484 EDC labor hours

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instead of 486 SDTM labor hours

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weeks instead of 20 for EDC go-live

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weeks instead of 8 to see SDTM data

Why you get more with ryze

ryze is the only platform that lets you design CRFs, create SDTM datasets, reuse content, as well as build studies for leading EDCs, and automate SDTM conversions – all in one cloud suite.

ryze is the only Clinical Metadata Repository that lets you design and visualize eCRFs inside the platform. You can see exactly how eCRFs look, and how they work for leading EDCs – without having to build your EDC and go back and forth between platforms to edit and review.

With ryze, you can build your study in a fraction of the time it normally takes – in as little as 6 weeks! Building studies from standardized content not only speeds up design, but also increases quality and consistency across studies and standards.

ryze is the only platform that supports such a breadth of CDISC, 3rd party, and in-house metadata. You can design CDISC metadata in any version of SDTM, ADaM, SEND, or NCI Controlled Terminology. Plus, you can design edit checks, EDC specific metadata, 3rd party lab transfer specs, mapping metadata, and analysis results metadata to name a few examples.

With ryze, you can transfer metadata between various platforms – such as EDCs – and continually reuse it. There’s no need to redesign, retype, or retest content if you switch EDCs for example. Just move your assets and reuse them. ryze is the only EDC vendor neutral platform that gives this level of reusability across systems.

ryze is the only commercial off-the-shelf solution that’s available for use immediately, and requires very little ryze can be very quickly tailored to your specific needs, with no long or complex implementation.

ryze is the only solution used by CDISC to design CDASH example CRFs. They create, visualize, edit and approve eCRFs in ryze, then export them in ODM-XML to publish on their CDASH eCRF portal.

You get your first SDTM dataset conversions much faster with ryze – in as little as 4 weeks, or even less! As soon as patient data is live in the EDC, you can see it. So you can act upon trial data far quicker. In fact, our platform was recently used to determine safety and efficacy in several COVID vaccination studies.

Some of the organizations using Formedix

Testimonials

FAQs

Can I start using Formedix clinical trial software straight away?

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.

What support will I get using the Formedix clinical trial automation software?

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.

What are the benefits of Formedix clinical trial automation software?

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.

What are the benefits of using a clinical metadata repository?

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.

Does Formedix stay up to date with CDISC standards?

Yes. Formedix uses templates that are built on the latest CDISC standards, so you’ll automatically comply with the latest FDA and NCI standards.

Does Formedix integrate with other standards or systems?

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.

Got a project in mind?

Tell us what you’re trying to do, and we’ll show you how we can help.