Standards & Submissions
Standards that support reviewable delivery.
Veratryx provides CDISC-aligned data and programming support for FDA-facing and international clinical-development programs. Applicable standards and versions depend on the study, sponsor plan and relevant regulatory expectations.
01
From source data to final outputs
Clear derivation logic and controlled specifications connect source data, SDTM, ADaM and final reporting outputs.
SDTMADaMTables, listings and figuresMetadata and Define-XML where in scope
02
Submission-support scope
- Readiness review and remediation
- Reviewer documentation where in scope
- Response programming where in scope
- Reproducibility and traceability evidence
- Production validation and QC
03
Governed by your framework
Sponsor SOPs, approved systems, agreed acceptance criteria and final client approvals govern delivery. Requirements are aligned to the study rather than expressed as blanket compliance or certification claims.
Veratryx describes this work as CDISC-aligned and FDA-facing support where in scope; it does not imply regulator endorsement or guaranteed submission acceptance.
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