Want your SDTM datasets in 1 click?

Use our clinical trial automation software to make SDTM datasets upfront. You can even create them before you’ve collected any patient data. That way, you get SDTM conversion done early on, and can check that your datasets will meet regulatory requirements. You also get a head start on mapping your ADaM datasets back to SDTM.

Easily design datasets

Templates let you add domains and variables that are compliant with the relevant versions of CDISC standards. Tailor them to your needs by adding additional metadata – such as supplemental qualifiers, derivation methods and value list metadata. Our clinical metadata management tools help ensure that your datasets comply with CDISC Define-XML, CDASH, SEND, SDTM and ADaM standards.

Create standards for reuse

You can arrange your datasets into organizational standards for reuse in future. This increases data quality and saves so much time and resources.

Easily manage CRO specs

Use ryze to make specifications if you’ve got a CRO designing datasets for you. When you get datasets back, simply check them against your original specs to ensure they’re as you expected.

What will my datasets look like?

See how your SDTM datasets will look to regulators reviewing your submission. Either PDF or HTML format. This includes links to pages in external documents, like Annotated CRFs.

Your study can also manage other metadata in ryze, such as SDTM mappings. These describe how the original (or source) datasets from your EDC system map to the CDISC SDTM standard. Our CDISC SDTM mapping tools let you make and validate simple variable to variable mappings, as well as more complex mappings with many steps.

Upfront mappings

Mapping data upfront helps ensure that all the relevant data is collected. ryze clinical trial building and automation software shows what your EDC datasets will look like – before you get them. So you can do your mappings early on. Then crack on making your SDTM define.xml files once your first EDC datasets are ready.

And if you include SDTM mappings in your organizational standards, you can easily re-use them. That means faster study designs, and better quality data.

Human-readable mappings

In ryze, you make human-readable mappings that clearly describe how datasets and variables in your original (source) datasets map to their equivalents in SDTM. From there you can create a metadata specification for programmers.

Machine-readable mappings

You can also create machine-readable mappings with our easy-to-use mapping language in ryze. No programming knowledge is needed. Once your mappings are done and approved, use them to turn your source datasets into SDTM datasets (using our templates). You’ll save time and money as there’s no need for programmers to double program data conversions from your specifications. Reports give you full traceability of all mappings to ensure data is accurately mapped.