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Our clinical trial software for Pharmas gives you the advantage in study design and build.
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.
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.
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.
ryze clinical trial software for Pharmas 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.
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.
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.
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!
You need to see your trial data ASAP. ryze can give you SDTM conversions in as little as 4 weeks – usually less.
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!
ryze is built on the latest CDISC compliant templates, so you automatically comply with the latest FDA and NCI standards.
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 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.
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.
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.
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 3rd 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.
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.
Whether you’re doing it yourself, or outsourcing to a CRO, ryze clinical trial software for Pharmas accommodates how you want to work.
Share your standards library with CRO
CRO designs your study based on standards
CRO builds your EDC and converts to SDTM
You design a study using library & new content
CRO builds your EDC and converts to SDTM
You design a study using library & new content
You build EDC and convert datasets to SDTM with 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.
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.
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.
You can get your SDTM conversion in as little as 4 weeks – often in even less time than that!
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.
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.
The ryze metadata repository and clinical trial automation platform will help you design, build, and submit your trials much faster than before.
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