Find submission problems before filing pressure peaks.
Assess SDTM/ADaM structure, metadata, documentation, validation findings, lineage and study-to-study consistency—then prioritize remediation on the critical path to your regulatory deadline.
Submission gaps discovered too late cost time you don't have.
Most sponsors discover structural issues, metadata gaps and validation findings during final QC—when every day of rework pushes against filing deadlines.
Structural gaps
SDTM/ADaM domain structure, variable definitions and conformance issues that require dataset-level remediation.
Metadata gaps
Incomplete Define-XML, annotated CRF inconsistencies and missing derivation documentation.
Validation findings
Open QC issues, unresolved conformance checks and missing evidence for finding resolutions.
Assess, prioritize, remediate—with traceability.
Readiness assessment
Evaluate current SDTM, ADaM, metadata, validation status and lineage against sponsor standards and regulatory expectations. Identify gaps on the critical path.
Critical path prioritization
Rank remediation items by impact on submission timeline. Focus resources on what blocks delivery—not cosmetic improvements.
Focused remediation
Execute remediation with clear ownership, milestones and traceability. Every fix is documented, versioned and tied to the approval workflow.
Package and validate
Produce submission-ready datasets, metadata, documentation and validation evidence. Export deliverables aligned to your regulatory operations workflow.
Every artifact that regulators and QA will inspect.
- SDTM domain structure and conformance
- ADaM dataset structure and derivations
- Define-XML completeness and accuracy
- Annotated CRF alignment
- Validation findings and resolutions
- Lineage from source to submission artifacts
- Study-to-study consistency for integrated submissions
- TLF accuracy and specification alignment
| Area | Status | Priority |
|---|---|---|
| SDTM Conformance | Ready | — |
| ADaM Derivations | 3 gaps | High |
| Define-XML | Ready | — |
| aCRF Alignment | 2 gaps | Medium |
| Validation Evidence | 5 open | High |