Randomization design
Configure protocol-defined allocation, treatment arms, cohorts and controlled randomization rules for the study design.
Randomization and trial supply
Randomization and drug supply in one controlled workflow.
Galax IWRS brings participant randomization and investigational-product supply into the same system. It reduces manual reconciliation and shipment risk while giving authorized study teams a clear view from enrollment through accountability.
Galax IWRSRandomization and trial supply
- 01ConfigureTranslate allocation, cohort and supply rules from the protocol.
- 02RandomizeEnroll and assign participants through a controlled site workflow.
- 03SupplyMonitor inventory and coordinate site or depot resupply.
- 04ReconcileReview assignments and inventory movements through closeout.
Quality controlsConfigured, reviewed, traceable
Turn fragmented trial operations into one connected, transparent process.
OneRandomization workflow
LiveSupply visibility
FullOperational traceability
Capabilities
Purpose-built for the clinical workflow.
Product capabilities are organized around the work study teams need to control, review and deliver—not around disconnected technical features.
Participant assignment
Give authorized site users a guided enrollment and assignment workflow with immediate confirmation and role-based visibility.
Supply management
Track investigational-product availability across depots and sites, supporting study-level inventory oversight.
Shipment coordination
Connect enrollment demand with resupply decisions to reduce avoidable shortages, excess stock and manual handoffs.
Accountability & reconciliation
Maintain a controlled history of assignments, dispensing and inventory movements to support closeout reconciliation.
Access & oversight
Use role-based access, operational dashboards and audit records to keep sponsor, CRO and site activities visible.
Delivery workflow
One accountable path from setup to evidence.
Connect IWRS with Galax EDC for participant and visit context and with eTMF for controlled study documentation and inspection readiness.
Configure
Translate allocation, cohort and supply rules from the protocol.
Randomize
Enroll and assign participants through a controlled site workflow.
Supply
Monitor inventory and coordinate site or depot resupply.
Reconcile
Review assignments and inventory movements through closeout.
Quality and control
Designed for regulated clinical work.
Platform controls and documented operating procedures work together to support the sponsor's validated, risk-based use.
Role-based access
Permissions limit randomization, supply and oversight activities to authorized study roles.
Controlled configuration
Protocol rules and production changes follow defined review and release controls.
Complete audit history
Key participant, treatment and supply actions remain attributable and time-stamped.
Inspection support
Operational records and reports support sponsor oversight and trial reconciliation.
The connected suite
Contact
See how IWRS fits your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.
info@galaxbiotech.com