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.

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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

Uniquely with cloud-based ryze, you can do CRF designs, build your study for any EDC, create SDTM datasets and automate SDTM conversions, plus reuse content, all in one single platform.

As well as designing CRFs in ryze, you can also see exactly how they look for your chosen EDC – without leaving the platform or waiting for EDC build. This real-time visualization which enables rapid review and approvals is only possible with ryze.

ryze is unique in letting you build a full study from standards in the platform. After designing your study, click a button to automatically build the entire study for your chosen EDC, including edit checks and visit schedules.

With ryze, you can get your first SDTM datasets in 4 weeks or less! Immediately when data is available in the EDC, you can see it and make early informed decisions, in response to safety or efficacy findings for example. For this reason, the ryze platform was used in some prominent COVID vaccination studies.

Only ryze gives you the tools to build your study in just 6 weeks! Reusing standardized content and metadata and being able to automatically build your study dramatically accelerates clinical study build.

ryze supports the full range of CDISC metadata across all versions of SDTM, ADaM, SEND and NCI Controlled Terminology. Uniquely, the platform also handles 3^rd party, EDC and in-house metadata, and enables edit check design and analysis results metadata for example.

ryze is the only platform that lets you reuse metadata in its entirety, regardless of EDC system. So, you can reuse metadata content from different EDCs in ryze, without having to retest it.

ryze is the only clinical study software of its kind that’s available out-of-the-box. You can start using it straightaway, without waiting for anything to be built or programmed.

Only the ryze platform is used by CDISC to design, visualize, edit and approve CDASH compliant example CRFs. CDISC exports CRFs from ryze in ODM-XML and publish them on the CDASH eCRF portal.

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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

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

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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.

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