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/ EDC
Electronic Data Capture
Site-facing data capture that sites actually want to use.
Salvus EDC combines a no-code form designer, a declarative edit-check engine with a built-in test harness, risk-based SDV and CDISC-standard exports — built so per-study validation is fast and site adoption is frictionless.
Key capabilities
eCRF Form Designer
Edit-Check Engine
Visit Schedule & Dynamics
Risk-Based SDV / SDR
Medical Coding
Mid-Study Amendments
< 8 wks
Build to go-live average
300+
Edit checks per study
96.9%
AI extraction precision
ODM 2.0
Export standard
What it does
All the capability, none of the complexity.
Salvus CTMS gives sponsors, CROs and sites a single operational truth across protocol management, site activation, participant tracking, milestone control, and regulatory submission coordination. AI-assisted planning flags at-risk milestones before they slip.
01
eCRF Form Designer
Drag-and-drop builder with CDASH v2.x alignment on every field. WYSIWYG site preview. Annotated CRF PDF with SDTM annotations generated automatically.
02
Edit-Check Engine
No-code rule builder for univariate, cross-field, cross-form and cross-visit checks. Built-in test harness — test results stored as validation evidence.
03
Visit Schedule & Dynamics
Visual schedule-of-assessments builder with visit windows, log forms and dynamic field/form behaviour. Oncology cycles supported.
04
Risk-Based SDV / SDR
Per-field critical-to-quality flagging drives targeted verification plans. Monitor workbench shows assigned sites, broken verifications and field-level marks.
05
Medical Coding
MedDRA and WHODrug coding inline in EDC with AI suggestions for non-exact verbatims. Coder adjudicates every non-exact code.
06
Mid-Study Amendments
Amendment workspace: branch live study, run automated impact analysis, dry-run on cloned production data, deploy with dual e-signature.
07
SAE Handoff & Reconciliation
SAE form data generates E2B(R3) payloads to Salvus ICSR or third-party databases. Reconciliation workspace surfaces discrepancies.
08
CDISC Export & Archival
ODM-XML v2.0 API for CDMS. SDTM mapping with Define-XML v2.1. Full-fidelity archival export at database lock with audit trail.
How it works
From day one to every day after.
A typical journey through Electronic Data Capture — from onboarding to steady-state operations.
1
Build & UAT
Design forms and rules in Dev; promote to UAT; run the test harness and simulate full patient journeys. Deploy with e-signature approval.
2
Site go-live
Sites complete training gate before accessing production. Offline-tolerant entry and task-first home screen make adoption fast.
3
Clean & monitor
Auto-queries fire on save; manual queries from DMs and monitors. Risk-based SDV plan reduces verification volume without increasing risk.
4
Lock & archive
DM + sponsor dual-signature lock. ODM archival export with audit trail included. Site investigator file copy generated per market requirements.
See It in Action
Watch Clinical Trial Management System in action.
A guided walkthrough of the key workflows — built for Clinical Trial teams who need to see it to believe it.
Integrations
Connects where you need it to.
Electronic Data Capture is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.
Compliant with
21 CFR Part 11
CDISC CDASH v2.x
ODM-XML v2.0
ICH E6(R3)
GAMP 5
EU Annex 11
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