With ryze Clinical MDR & clinical trial automation software.
- Solutions
ryze
Formedix CORE
- Solutions
ryze
Formedix CORE
- Solutions
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Build clinical studies and run SDTM with greater speed and accuracy
ryze cloud based Clinical Metadata Repository & SDTM automation suite
ryze is the only off-the-shelf Clinical MDR and SDTM automation suite that enables faster study design, build and submission, whilst also improving quality and consistency across your studies and standards.
What can ryze clinical trial automation software do for you?
Clinical Metadata Repository
ryze Clinical MDR allows you to share, manage and reuse study content in one central library. You can harmonize your standards end-to-end, and as a result set up studies more efficiently. With ryze MDR as your foundation, you can use our automation tools to run SDTM and generate submission deliverables with greater speed and accuracy.
CDISC Compliance
When you design studies in ryze, you’ll automatically align with relevant industry standards. That includes all the different versions of CDISC SDTM, ADaM, SEND, and Define-XML. CDISC aligned templates are part of the ryze framework, allowing you to build compliant studies faster and more efficiently.
CDISC Compliance
When you design studies in ryze, you’ll automatically align with relevant industry standards. That includes all the different versions of CDISC SDTM, ADaM, SEND, and Define-XML. CDISC aligned templates are part of the ryze framework, allowing you to build compliant studies faster and more efficiently.
CRF design & EDC build
When you design studies in ryze, you can see exactly how eCRFs look and work for your EDC as you design. That way you can make any changes and gain approvals before building your study. Then click a button in ryze to build your full study, including EDC specific functionality such as edit checks and visit structures.
SDTM
ryze determines your raw source dataset variables when you design forms in the platform. Then our mapping tools help you match your source datasets to CDISC SDTM, so that you collect all the right trial data. Then it’s just one click to run conversions and generate your SDTM datasets – avoiding delays at submission.
SDTM
ryze determines your raw source dataset variables when you design forms in the platform. Then our mapping tools help you match your source datasets to CDISC SDTM, so that you collect all the right trial data. Then it’s just one click to run conversions and generate your SDTM datasets – avoiding delays at submission.
Visual Define-XML
Create your submission deliverables in the required formats with the help of ryze visual define xml editor. With your study built in ryze and datasets defined, it’s just one click in ryze to create your define.xml submission deliverable files, including STDM define.xml.
Validation
ryze handles all the various validations needed to validate your trial metadata. As well as validating CRFs, you can validate EDC designs against your specs and EDC rules, and validate your SDTM dataset designs against CDISC standards, NCI standards and FDA or PMDA rules.
Validation
ryze handles all the various validations needed to validate your trial metadata. As well as validating CRFs, you can validate EDC designs against your specs and EDC rules, and validate your SDTM dataset designs against CDISC standards, NCI standards and FDA or PMDA rules.
Did you know that ryze helped speed up Covid studies?
Watch the video to learn how ryze enabled faster study set up and earlier data insights on Covid trials.
How you’re better off with ryze
Easily find and share content
Metadata is stored in one central place, so it’s quick to find what you’re looking for and easy to collaborate.
Save time by reusing content
Never build studies from scratch again! Reuse metadata content in ryze and save time and effort on manual study setup.
Faster CRF approvals
See what forms look like for your EDC in ryze without having to build your EDC – enabling quicker approval cycles.
Build your study in 1 click
It’s 1 click to build your full EDC study from standards in ryze. Saving time on study build means trials can start much sooner!
Effortlessly comply with CDISC
Save time and effort on compliance when you build studies in ryze. The platform uses CDISC templates, including NCI CT.
Get earlier data insights
ryze lets you run SDTM conversions from 1st patient in – so you can instantly make safety and efficacy decisions.
Organizations using our clinical trial software
What people say about us
FAQs
Does ryze stay up to date with all versions of CDISC?
ryze supports all version of CDISC standards, including old versions. It’s kept in line with all CDISC and NCI standard updates – so you’re always compliant.
Do I have to use all of the features in ryze?
No. We understand that different organizations have different needs. You can access all of the features in ryze and choose the ones you want to use. For example, some organizations might just want to use the metadata repository to store and manage standards. Some might want to design and build EDC studies. And others might want to use all of the features for their end-to-end studies. It’s entirely up to you.
Can my system integrate with ryze?
Yes. You can log in to your own system and our API automates the upload, conversion and download of clinical data.
What support is available for ryze?
We have a professional services team in place to help and support you. And you get your own dedicated account manager. If there’s something you need doing, it’s no problem. Just let us know what it is.
Can I standardize my content in ryze?
Yes. You can create content from scratch in ryze and standardize it using configurable governance processes that you can set to suit your organization’s needs. You can also import standardized content from your EDC or e-clinical database. By using pre-approved content, you know it’s complete and correct.
Are SDTM conversions automated?
Yes. Once you’ve set up your mappings, it’s just 1 click to convert your compliant SDTM datasets.
Test data
CDISC have provided test data for you to try out the Formedix CORE platform and see how to validate study data in practice. The test data is included in the Formedix CORE downloadable zip file.
The ryze metadata repository and clinical trial automation platform will help you design, build, and submit your trials much faster than before.
VAT No. GB 671715037
Company number SC159080