Role-based access
Permissions limit randomisation, supply and oversight activities to authorised study roles.
IWRSRandomisation and trial supply
Randomisation and drug supply in one controlled workflow.
Galax IWRS brings participant randomisation and investigational-product supply into the same system. It reduces manual reconciliation and shipment risk while giving authorised study teams a clear view from enrolment through accountability.
- One
- Randomisation workflow
- Live
- Supply visibility
- Full
- Operational traceability
Capabilities
Turn fragmented trial operations into one connected, transparent process.
8 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Randomisation methods
Simple, block, permuted and variable block, stratified block, unequal allocation, minimisation (Pocock–Simon), biased coin (Efron), urn and assign-based rules, with lists generated or uploaded, versioned and locked.
- 02
Dose escalation & titration
Enrol subjects into the open dose cohort, let the committee open and close cohorts, and manage dose titration at later visits.
- 03
Subjects, dispensing & envelopes
Screen and randomise subjects with immediate confirmation, dispense, replace and verify kits at visits, and keep each subject's randomisation envelope sealed for blinded users.
- 04
Kits & depots
Register, prepare, QC and release kits; manage depots and their stock; scan barcodes and QR codes and print kit labels.
- 05
Shipments & supply forecasting
Initial, resupply and manual shipments with site receipt, resupply triggers per site, a supply map with days of supply left, demand forecasting with suggested shipments, and direct-to-patient delivery.
- 06
Accountability & quality
Kit returns and unit counts, compliance, monitor verification and destruction; temperature excursions with quarantine and QA decision; expiry extension and relabelling.
- 07
Blinding & emergency unblinding
24/7 emergency code-break by subject number and card code, emergency cards, unblinding requests and blinding-risk checks, with every unblinding logged.
- 08
Oversight, validation & integration
Enrolment dashboard, simulation of randomisation and supply before go-live, a validation pack, reports, alerts, an audit trail, and an integration API with webhooks. Randomisations are written back to Galax EDC.
How it works
One accountable path from set-up to evidence.
Connect IWRS with Galax EDC for participant and visit context and with eTMF for controlled study documentation and inspection readiness.
- 01
Configure
Translate allocation, cohort and supply rules from the protocol.
- 02
Randomise
Enroll and assign participants through a controlled site workflow.
- 03
Supply
Monitor inventory and coordinate site or depot resupply.
- 04
Reconcile
Review assignments and inventory movements through closeout.
Quality and control
Designed for regulated clinical work.
Platform controls and documented procedures support the sponsor's validated, risk-based use.
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.
Who uses it
- Supply manager
- Unblinded pharmacist
- CRC
- CRA
- Data manager
Pricing
Licence fee.
Fees in USD, exclusive of taxes. Set-up and build fees are one-time and quoted separately.
Galax IWRS / RTSM
Randomisation and trial supply
$1,800per month
$21,600per year
Request a quoteBuild a quote →Rate card GLX/RATE/2026-27/003.
Contact
See Galax IWRS on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.