Build clinical studies and run SDTM with greater speed and accuracy

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.

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.

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.

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.

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.

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.