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/ RTSM / IRT
Randomization & Trial Supply Management
AI-native randomization and supply — from design to accountability.
Salvus RTSM handles every complexity of modern trial supply: adaptive randomization, multi-depot inventory, blinded and unblinded role enforcement, expiry management and real-time allocation — with a Supply Copilot that spots shortfalls before they occur.
Key capabilities
Randomization Design Studio
Real-time Treatment Allocation
Blinding & Unblinding
IP Inventory & Expiry Management
Forecasting & Resupply
Accountability & Reconciliation
2,840
Randomizations this month
99.97%
Allocation uptime
34
Depots managed
< 2s
Allocation response time
What it does
All the capability, none of the complexity.
Salvus RTSM handles every complexity of modern trial supply: adaptive randomization, multi-depot inventory, blinded and unblinded role enforcement, expiry management and real-time allocation — with a Supply Copilot that spots shortfalls before they occur.
01
Randomization Design Studio
Simple, stratified, minimization, adaptive and block designs. Multi-arm and factorial layouts. Import or generate lists with full audit trail per version.
02
Real-time Treatment Allocation
Sub-second allocation via portal, IVR and API. Idempotent retry safety. Blinding enforced at the data layer — unblinded roles see only what the protocol permits.
03
Blinding & Unblinding
Configurable blinding profiles per role. Emergency unblinding via dual-control workflow with mandatory reason capture, sealed in a permanent audit record.
04
IP Inventory & Expiry Management
Kit tracking from manufacture to patient — per depot, per site. Automated expiry alerts, quarantine actions and destruction records.
05
Forecasting & Resupply
Enrolment-driven demand projection with Monte-Carlo simulation. Resupply triggers fire automatically; Supply Copilot explains recommendations in plain language.
06
Accountability & Reconciliation
Dispensing records, returns and destruction captured at site. Accountability reports generated on demand for regulatory submission and audit.
07
Depot & Distribution Management
Multi-depot routing logic, cold-chain flag support, country-specific import documentation and transfer orders with full chain-of-custody.
08
L0–L4 Automation Levels
Every automated action assigned an autonomy level. Resupply proposals (L2) surface for human approval; allocation decisions (L4) are deterministic rules — never AI inference.
How it works
From day one to every day after.
A typical journey through Randomization & Trial Supply Management — from onboarding to steady-state operations.
1
Design
Configure the randomization scheme, stratification factors, arms and supply rules in the Design Studio. Simulate allocation distributions before going live.
2
Activate
Load validated randomization lists, activate depots and sites. UAT subjects run end-to-end — allocation, dispensing, and reconciliation — before first patient in.
3
Operate
Sites allocate and dispense; inventory updates in real time. Supply Copilot monitors stock levels 24/7 and proposes resupply waves for coordinator approval.
4
Close out
Generate accountability reports, reconcile all kits, document returns and destruction. Lock the randomization database with a full audit package.
See It in Action
Watch Randomization & Trial Supply Management 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.
Randomization & Trial Supply Management 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)
21 CFR Part 11
EU Annex 11
GAMP 5
ICH Q10
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