Custom CDISC tooling for pharma, biotech, and CRO teams: standardized datasets, machine-readable metadata, automated reporting, and the conformance evidence a submission has to carry, all traceable back to source.
Getting from collected data to compliant CDISC datasets is detailed, repeatable work. We build pipelines driven by metadata and specifications, so the same study can be rebuilt the same way every time, and every value can be followed back to the record it came from.
Controlled Terminology is applied and version-controlled throughout, so coded values stay consistent across datasets and across the studies in a programme.
Metadata is a contract. When define.xml is generated from the same specifications that build the datasets, the documentation and the data stay in step, and a reviewer sees exactly what they are looking at.
We generate and validate define.xml today and produce Dataset-JSON where sponsors are moving to it, so your submission is ready for the format the authorities expect next.
Read: define.xml as a contractClinical study reports rest on tables, listings, and figures that have to be correct and reproducible. We build reporting pipelines that produce submission-ready output from your ADaM datasets and carry quality control through every step.
When reporting is reproducible, a late data change does not mean starting over. The pipeline reruns, the quality checks repeat, and the output is ready again in a fraction of the time manual reporting would take, with double-programming checks built into the process.
A submission is more convincing when the conformance story is complete. We run Pinnacle 21 and CDISC CORE style checks against SDTM, ADaM, and define.xml, resolve findings, and turn what remains into documented, defensible evidence rather than a list of open issues.
The result is a filing that is complete, traceable, and easy to inspect for FDA, PMDA, and other authorities, which keeps reviews moving and questions to a minimum.
Read: turning Pinnacle 21 output into evidenceWe do not resell a fixed product. These are tools we build and configure to your SOPs, your data standards, and your therapeutic areas, drawing on our clinical software platforms, our AI capabilities, and our R4SUB submission-readiness work.
Each tool is built on our clinical data platforms, then set up and qualified for your environment.
Our R4SUB tooling turns the ready-to-file decision into a reproducible Submission Confidence Index, built from conformance and metadata evidence.
The practical points teams raise before we start.
Yes. We configure and qualify each tool against your standard operating procedures, data standards, and therapeutic areas, and deliver the evidence to support regulated use.
We can. We run Pinnacle 21 and CDISC CORE style checks against datasets and define.xml you already have, resolve findings, and document what remains as defensible evidence.
Yes. We build the full path from collected data to SDTM and ADaM, generate matching define.xml, and produce submission-ready tables, listings, and figures, all from one traceable pipeline.
We prepare datasets and transport files in the formats FDA and PMDA expect, and structure packages so other authorities can inspect them cleanly.
Tell us where your study is and what you are filing. We can map a practical path from your data to a submission that holds up to review.
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