Randomisation and supply, on the same patient record as everything else.
Randomisation is a moment where several systems have to agree: the patient exists, is eligible, is consented on the current ICF, and a kit is available at their site. When those facts live in one platform, randomising is one action.
- Randomisation
- Kit allocation
- IP accountability
- Excursions
- Kits on site
- 412
- Dispensed
- 96
- Quarantined · excursion
- 14
- Expiring in 60 days
- 22
- Sites below resupply level
- 2
One inventory, read by every role that touches it.
Everyone who touches the supply chain, in one place with the right access.
Coordinating investigational product means six roles needing six different slices of the same information. Embedded in the platform, it is one inventory with access gated per role.
Central lab
Shipments, receipts and sample logistics for its sites — without treatment assignment.
Clinical trial manager
Inventory across every site, resupply triggers and excursions, before a site runs short.
CRA
Reviews IP accountability at the visit, against the records the pharmacist entered.
Site pharmacist
Receipt, storage, dispensing and returns, with excursions recorded on the affected kits.
Site nurse and coordinator
Randomises and dispenses at the visit, on the same patient record as the eCRF.
Principal investigator
Site accountability, and the permissioned, recorded route to unblind when necessary.
What one allocation sets in motion.
The patient is randomised once. Everything else is a consequence of the same record.
- PatientsStatus moves to randomised
- VisitsVisit windows calculated from day 0
- SupplyKit B-1182 marked dispensed at Site 04
- eCRFBaseline forms opened for the visit
- AnalyticsEnrolment counters updated live
- Audit trailAllocation recorded with actor and timestamp
Allocation through accountability.
Randomisation
Simple, block and stratified schemes, configured per study.
Kit allocation
Kits assigned from site inventory at randomisation or dispensing.
Blinding control
Assignment visible only to entitled roles. Unblinding is permissioned and recorded.
Supply at site level
Inventory per site, resupplied on consumption rather than a fixed schedule.
Excursion handling
Affected kits quarantined and traced to shipment and to any patient dispensed.
IP accountability
Dispensed, returned and destroyed, reconciled per site and reviewed at the visit.
Common questions
IWRS, IRT, RTSM — what is the difference?
They largely describe the same system at different points in its history. IWRS (interactive web response system) replaced IVRS, the telephone version. IRT (interactive response technology) is the vendor-neutral term. RTSM (randomisation and trial supply management) describes what it does rather than how it is accessed, and is the term most sponsors now use. If you are comparing products, treat them as the same category.
Which randomisation methods are supported?
Simple, block and stratified randomisation, with block sizes and stratification factors configured per study. The allocation list is generated and held so that assignment is reproducible and auditable.
How is blinding maintained?
Treatment assignment is visible only to roles entitled to see it. Unblinding is a deliberate, permissioned action that is recorded with actor, timestamp and reason, and it is visible in the audit trail rather than being an untracked event.
Does it handle temperature excursions?
Excursions are recorded against the affected kits, which are quarantined until dispositioned. The kits remain traceable to the shipment they arrived in and to any patient they were dispensed to.
Connected in the same platform
Bring your randomisation scheme.
30 minutes with a founder. We'll configure the scheme and the kit list, then randomise an illustrative patient and follow what it changes.