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← Clinical Trial Suite  /  CDMS

Clinical Data Management System

Clean, locked and submission-ready data — without the spreadsheet archaeology.
Salvus CDMS is the data management operations layer above the EDC: cross-study discrepancy analytics, DMP execution, coding, medical review listings and database lock governance. AI-assisted query management cuts the time from data entry to lock-ready by 40%.
Key capabilities
Data Validation
Cross-Study Analytics
Medical Coding
Query Management
DMP Execution
Database Lock & Unlock
< 8 wks
Avg. time to database lock
98.4%
First-pass data quality rate
27
Studies active in parallel
CDASH / SDTM
Standards compliance
What it does

All the capability, none of the complexity.

Salvus CDMS is the data management operations layer above the EDC: cross-study discrepancy analytics, DMP execution, coding, medical review listings and database lock governance. AI-assisted query management cuts the time from data entry to lock-ready by 40%.
01
Data Validation
Configurable validation rules beyond the EDC edit-check layer: cross-domain, cross-visit and statistical plausibility checks run as batch jobs or on demand.
04
Query Management
Automated query generation from validation failures, manual query creation, and AI-drafted query text for site-friendly wording and consistent phrasing.
07
CDISC Export & Define-XML
SDTM dataset generation with Define-XML v2.1 metadata. CDASH-annotated eCRF package. Conformance pre-checks before handoff to stats.
02
Cross-Study Analytics
Portfolio-level discrepancy heatmaps and quality trends across studies — site-level and CRO-level roll-ups for oversight reporting.
05
DMP Execution
DMP version control with task checklists: coding, reconciliation sign-off, blind review documentation and lock-readiness status per study.
08
Audit Trail & 21 CFR Part 11
Immutable field-level audit trail with before/after values, reasons and identity. True-copy export for inspections. E-signatures on lock events.
03
Medical Coding
MedDRA and WHODrug coding with AI-suggested codes for non-exact verbatims, coder adjudication, synonym management and mid-study dictionary upgrades.
06
Database Lock & Unlock
Lock workflow with configurable checklist. Controlled unlock with dual e-signature, scope limitation and full re-lock audit package.
How it works

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