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/ CDMS
Clinical Trial Management System
Orchestrate every study phase — from first site to database lock.
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.
Key capabilities
Protocol & Study Setup
Site Identification & Activation
Participant Tracking
Milestone Monitoring
IMP & Supply Integration
Regulatory & Safety Coordination
47
Active studies
312
Sites managed
18,400
Participants enrolled
94%
Milestone on-time rate
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
Protocol & Study Setup
Version-controlled protocol repository with amendment tracking. AI-powered amendment impact analysis propagates changes to site documentation and CRF specifications automatically.
02
Site Identification & Activation
Feasibility questionnaires, site scoring, regulatory submission tracking and site initiation visit checklists — all in one view per country and site.
03
Participant Tracking
End-to-end subject lifecycle from pre-screening through completion or withdrawal, with enrolment projections vs plan and screen-failure analytics.
04
Milestone Monitoring
Configurable milestone templates per phase. AI burn-down analysis predicts at-risk deliverables up to 8 weeks ahead and proposes corrective actions.
05
IMP & Supply Integration
Real-time inventory view per depot and site, reconciled with Salvus RTSM/IRT. Expiry alerts, resupply triggers and accountability summaries.
06
Regulatory & Safety Coordination
Submission tracker (IRB/IEC, HA) with deadline management. Seamless SAE handoff to Salvus ICSR for expedited reporting workflows.
07
Budget & Contract Management
Site contract lifecycle, payment milestones and cost-per-subject analysis across the portfolio with variance tracking.
08
Analytics & Oversight
Real-time dashboards for executive, sponsor and site views. Exportable listing packages for TMF reconciliation and inspection readiness.
How it works
From day one to every day after.
A typical journey through Clinical Trial Management System — from onboarding to steady-state operations.
1
Protocol ready
Load the approved protocol; AI extracts the schedule of assessments, visit windows and endpoint definitions into a draft study plan for sponsor review.
2
Sites activated
Run feasibility scoring, track regulatory submissions and site initiation — milestones auto-flag when any critical-path item falls behind.
3
Trial executed
Enrolment, visit compliance, deviation capture and supply reconciliation run in real time. At-risk signals surface in the ops dashboard before they become issues.
4
Study closed
Data lock, regulatory submission coordination and TMF reconciliation are tracked to completion — with one-click audit-ready export for inspections.
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.
Clinical Trial Management System is designed to work with the rest of the Salvus platform — and with third-party systems your team already uses.
Compliant with
ICH E6(R3) GCP
21 CFR Part 11
EU Annex 11
GAMP 5
ICH E8(R1)
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