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With built-in IWRS, you can manage randomization and drug supply from the same system, reducing manual reconciliations and shipment errors.
The eTMF module keeps essential documents organized, versioned and inspection-ready in real time. Together, these modules give you end-to-end visibility from startup to closeout.
We turn fragmented trial operations into one connected, transparent process.
Eight modules covering the full randomization and trial supply lifecycle.
Configure blocked, stratified, and ratio-based randomization to match the protocol exactly. Stratification factors, block sizes, and allocation ratios are versioned study metadata; randomization lists can be system-generated or imported from your unblinded statistician, with the list itself sealed from blinded roles.
Register, screen, and randomize subjects against protocol-defined eligibility gates. Screen failures, re-screens, discontinuations, and completions are all controlled transactions — each with confirmation messaging to the site and notification to the study team.
Dispense the right kit at the right visit with visit-window enforcement, replacement-kit workflows for damaged or lost units, and dose titration rules that select kits based on captured response data. Every dispensation is blinded, logged, and tied to the subject record.
Set site-level thresholds, buffer stock, and prediction windows; the system triggers depot-to-site shipments automatically as randomization consumes inventory. Shipment workflows cover request, approval, dispatch, receipt, and quarantine — with temperature-excursion holds until release.
Kit-level visibility across depots and sites: lot numbers, expiry dates, and status (available, allocated, dispensed, returned, destroyed). Expiry horizon reports and automatic do-not-dispense locks keep short-dated stock out of subjects' hands.
Emergency code breaks are role-restricted, reason-required, and immediately notified to the medical monitor and sponsor-designated contacts. Planned unblinding at database lock follows a controlled, documented release — and unblinded reports never leak into blinded roles.
Returns, destruction, and site-level accountability logs reconcile automatically against dispensing records. Discrepancies surface as tasks, not surprises — keeping close-out reconciliation a review, not an investigation.
Real-time views of randomization progress by stratum, inventory health by site, shipments in transit, and expiry exposure. Configurable email/system notifications keep sites, CTMs, and supply managers ahead of events — with native integration to Galax EDC and export for supply forecasting.
Supply problems announce themselves early — if you're watching the right signals:
1 site below threshold
resupply SHP-0114 in transit
Randomization and supply decisions are among the most inspected events in a trial. Galax IWRS is engineered accordingly.
Electronic records, e-signatures, audit trails, and access controls built into the platform architecture.
Controlled workflows, oversight, and documented review consistent with E6 expectations.
Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available.
Complete audit trails, reason-for-change capture, versioned records, and access logs on demand — with validation-friendly documentation for your CSV activities.
Compliance is a shared responsibility: Galaxbiotech provides the technical controls and documentation to support your regulated processes; certification claims are made only where formally established.