Get a head start with ryze - build your study in as little as 6 weeks!

Q: How quick is it to get started using Formedix?

You can get started with Formedix straight away. Start by importing your content. Use the built in templates to create your SDTM datasets, or auto-generate specifications to give to your CRO. Reusing standardized content means your study will be better quality. If you outsource, you can check work against specifications generated in Formedix. Built in CDISC standards, means successful regulatory submissions. You can get products to the market faster and maximize your profits.

Q: How can Formedix help with regulatory compliance?

With Formedix it’s easy to automatically create specifications. If you’re working with a CRO, you can validate the datasets you get back from them against your specifications for accuracy and regulatory compliance. Formedix is built on the latest CDISC compliant templates, so you’ll also you automatically comply with the latest FDA and NCI standards.

Our cloud-based Clinical Metadata Repository and automation suite gives you the advantage in study design and build.

clinical-mdr-pharmas-reuse-manage-standards

Fast track study build and launch medicines faster.

Time is money when it comes to launching medicines. You need to design, build and submit your study for approval ASAP to get products to market. ryze fast tracks this entire process. Now you can do all those manual, time-consuming tasks quickly and easily with our Clinical Metadata Repository and automation suite. Download our flyer for more information.

Start trials far quicker

Have your study set up ready to start trials in record time. Upload your existing content to ryze straightaway. And use our templates to make your SDTM datasets up front. Or if you’re outsourcing to a CRO, use our auto-generated specifications to quickly and easily make your specs.

Improve study quality

Increase the quality of your study by reusing content from your organizational standards in ryze. No need to retype stuff every time. So there’s no risk of manual errors, and you increase the accuracy of your study data. If you outsource to a CRO, check their work against your specs in ryze to find any errors and increase quality.

Increase chances of FDA approval

The ryze platform is built on the latest CDISC standards. So your study design and data automatically complies with FDA and PMDA regulations. This helps to increase your chances of a successful, approved submission.

Maximize profits

Quicker EDC launch and faster SDTM data visibility ensures higher quality studies, and gets you to submission faster. And the sooner you get FDA approval, the faster you can bring products to market – with the same or fewer resources! That means scope to run more trials and launch more products over time.

What can I do with ryze?

How you’re better off with ryze

Start your study pronto

Instantly bring your library of forms, datasets or legacy forms into ryze. Then crack on with EDC design & build. Or get your CRO straight on it. If it typically takes 20 weeks for you to set up a study without ryze, it can take as little as 4 weeks with ryze. That’s a huge time saving.

Preview stuff first

See what CRF designs, datasets, and mappings will look like before you start your trial. All at the push of a button. You choose the format – Excel, Word, PDF… Make any changes. Preview again, and repeat until you’re happy!

Get your datasets much faster

You need to see your trial data ASAP. ryze can give you SDTM conversions in as little as 4 weeks – usually less.

Easily make changes mid study

Your source and SDTM datasets are ready and mapped upfront, before the trial. So it’s easy to make amends during your study without causing delays in the process. Make changes, then refresh your data to see what it looks like now. Simple!

Effortlessly comply with standards

No worries about meeting regulatory standards. ryze is built on the latest CDISC compliant templates, so you automatically comply with the latest FDA and NCI standards.

Reuse content

Build your organizational standards in ryze, and reuse this content forever more. Whether it’s forms, edit checks, dataset designs or mappings… do it once, get it approved, and there’s no retyping.

Choose your EDC & build faster

Choose just about any EDC to build your study in (we’ve got plug-ins for 7). Even use different EDCs for different study phases. Timescales? With ryze, you can build your study in as little as 6 weeks.

Save conversion time

ryze shows what your source datasets will be, really early on. Way before you’ve collected any patient data, you’ll know your variables (column headings). Based on this, you can design your SDTM datasets. And that means you can do your SDTM mappings early too. By the time you get trial data back, your datasets are all mapped, and it’s just 1 click in ryze to do your SDTM conversion.

More consistent data

Reusing content – rather than typing it out each time – cuts out mistakes and human error. And because it comes from your internal standards, you’re using pre-approved, consistent content across clinical studies.

Some of the organizations using our platform

Testimonials

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, 3^rd 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 configuration. 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.

0

instead of 1,484 EDC labor hours

0

instead of 486 SDTM labor hours

0

weeks instead of 20 for EDC go-live

0

weeks instead of 8 to see SDTM data

Get quality from your CRO

Working with a CRO? You can automatically make specifications in ryze to pass over to them. Once you get datasets back from the CRO, you can validate them against your specs for accuracy and regulatory compliance.

Want to make changes mid study?

With ryze, you have your SDTM datasets all done and mapped before the trial starts. So if you make changes mid study, just refresh your datasets to see what they look like with your changes.

Pharmas & biotechs can work in-house or outsource

Whether you’re doing it yourself, or outsourcing to a CRO, ryze accommodates how you want to work.

CRO designs, builds & converts to SDTM

Share your standards library with CRO

CRO designs your study based on standards

CRO builds your EDC and converts to SDTM

You design, CRO builds study

You design a study using library & new content

CRO builds your EDC and converts to SDTM

You design, build & convert to SDTM

You design a study using library & new content

You build EDC and convert datasets to SDTM with ryze

Clinical metadata repository and automation tools

formedix-metadata-repository-clinical-trial-software

Got a project in mind?

Tell us your requirements or what’s giving you grief, and we’ll see if we can help.

FAQs

How quick is it to get started using ryze?

You can get started with ryze straight away. Start by importing your content. Use the built in templates to create your SDTM datasets, or auto-generate specifications to give to your CRO. Reusing standardized content means your study will be better quality. If you outsource, you can check work against specifications generated in ryze. Built in CDISC standards, means successful regulatory submissions. You can get products to the market faster and maximize your profits.

How easy is it to make mid study changes?

Very easy! You can create your SDTM datasets and get them mapped before the clinical trial starts. If you need to make changes mid study, all you need to do is refresh your datasets. Then, you can see what your changes look like.

How can ryze help with regulatory compliance?

With ryze it’s easy to automatically create specifications. If you’re working with a CRO, you can validate the datasets you get back from them against your specifications for accuracy and regulatory compliance. ryze is built on the latest CDISC compliant templates, so you’ll also you automatically comply with the latest FDA and NCI standards.

How quickly can I get datasets using ryze?

You can get your SDTM conversion in as little as 4 weeks – often in even less time than that!

How does ryze help with consistent data?

By allowing you to reuse your standardized content. This removes the possibility of human error. Your content has already been approved – so that means you’ll have consistency across all your organizational standards and studies.

What previews will I be able to see?

You can see what your CRF designs, datasets, and mappings will look like before you start your trial. Simply choose what format you want, for example Excel, Word, PDF.

ryze

ryze FEATURES

ryze BY SECTOR

Clinical Trial Professional Services

Training Services