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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.
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.
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.
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.
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.
How it works
From day one to every day after.
A typical journey through Clinical Data Management System — from onboarding to steady-state operations.
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Study setup
Import the study definition from EDC; configure validation rules, coding dictionaries and the DMP checklist.
Ongoing cleaning
Validation jobs run nightly and on demand. AI-drafted queries go to sites; coding queue managed by coders with AI-suggested terms.
Blind review
Lock-readiness dashboard turns green as items close. Blind data review meeting package generated automatically.
Lock & export
DM + sponsor dual e-signatures lock the database. SDTM + Define-XML package generated and transferred to statistical programming.
See It in Action
Watch Clinical Data Management System in action.
A guided walkthrough of the key workflows — built for Clinical Trial teams who need to see it to believe it.
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How to add your demo video
1. Upload the Clinical Data Management System demo to YouTube.
2. Copy the video ID from the URL — the part after watch?v=
3. In the HTML above, find: data-vid="PASTE_VIDEO_ID_HERE"
4. Replace PASTE_VIDEO_ID_HERE with your actual video ID.
5. Save & deploy — the play button handles the rest automatically.
Integrations
Connects where you need it to.
​Clinical Data Management System is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.
Primary data source via ODM API
RTSM / IRT
Randomization events & dispensing
Study context & milestone alignment
SAE reconciliation
Compliant with
CDISC CDASH v2.x
SDTM/SDTMIG
ODM-XML v2.0
Define-XML v2.1
21 CFR Part 11
ICH E6(R3)
See Clinical Data Management System in a live demo.
Walk through a real workflow with a Tesserblu subject-matter expert.
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