Allocation
Blinding Depends on Process Discipline
When allocation lists live in spreadsheets or envelopes, blind protection depends on file access and memory. That is hard to evidence at inspection.
Randomization and Trial Supply Management
Randomization and IP Supply Management for Blinded Trials.
Clinera RTSM runs allocation, tracks every kit from depot to dispensing and triggers resupply before a site runs short.
- Block, Stratified and Adaptive Allocation
- Kit-Level Global Inventory
- Automated PAR Resupply
- Part 11 Emergency Unblinding
The Operational Risk
Where Allocation and Supply Go Wrong.
Randomization and drug supply fail quietly. A stratum drifts, a site runs down to two kits or a shipment has an excursion. Clinera RTSM brings those events into one controlled record.
Supply
Stock-Outs and Overage Happen Together
Sites run short while depots hold expiring stock because resupply follows review cycles instead of actual dispensing and site inventory.
Exceptions
Excursions and Unblinding Drift to Email
Temperature excursions and emergency unblinding are the events inspectors ask about, yet they are often recorded outside the trial system.
Controlled System
Allocation and Supply in One Controlled System.
Clinera RTSM executes the randomization algorithm and owns kit status from depot receipt to destruction, keeping allocation, dispensing and inventory consistent by construction.
01
Five Allocation Engines
Permuted block, stratified block, dynamic minimization, adaptive allocation and list import.
02
Kit-Level Traceability
Every kit is tracked by label, lot and expiry through defined supply status transitions.
03
Resupply on Consumption
PAR levels and reorder quantities generate shipment manifests when a site falls below threshold.
04
Exceptions With Evidence
Excursion quarantine and emergency unblinding produce complete, timestamped records.
How It Works
From Randomisation Schedule To Dispensed Kit
Four stages, running continuously for the life of the study rather than as a startup sequence.
Stage 01
Configure
Select the allocation engine, define arms, strata, block sizes and the roles permitted to see anything treatment-related.
Stage 02
Stock
Kits are registered by label, lot and expiry at the depot, then shipped to sites and receipted into site inventory.
Stage 03
Randomise And Dispense
A subject is allocated by the engine, a kit is reserved from available site stock, and dispensing moves it out of inventory.
Stage 04
Resupply And Reconcile
Falling below PAR triggers a manifest, while returns, quarantine and destruction close out every kit that was ever shipped.
Capabilities
Core RTSM Features and Capabilities.
Five modules cover allocation, global kit inventory, automated resupply, cold-chain exception handling and emergency unblinding.
Feature 01
Advanced Randomization Engines
Run the allocation method the protocol calls for, with blind protection enforced by the system.
- Permuted block - Fixed or variable block sizes for balanced allocation across arms.
- Stratified block - Balance maintained within strata such as site, disease severity or age band.
- Dynamic minimization - Allocation weighted to reduce imbalance across multiple prognostic factors.
- Adaptive allocation - Ratios that shift during the study where the design calls for it.
- List import - A statistician-generated schedule loaded and executed without exposing it to study staff.
- Unblinding protection - Treatment-revealing data withheld from blinded roles across screens, exports and reports.
Engine Configuration
Dynamic Minimization
SiteWeight 2
SeverityWeight 3
Age BandWeight 1
Blinded Preview
Subject 014 randomized. Kit reserved. Treatment assignment hidden from site coordinator view.
Feature 02
Global Kit Inventory and Status Tracking
Know where every kit is, what state it is in and when it expires.
- Depot to site tracking - Each kit followed by label, lot number and expiry date across the supply chain.
- Defined status transitions - Inventory, reserved, dispensed, returned, quarantined and destroyed states recorded for every movement.
- Expiry visibility - Stock approaching expiry identified at depot and site level before it becomes waste.
Global Inventory
Depot to Site Tracking
In Inventory
Receipted and available at depot or site.
Reserved
Allocated to a subject, not yet handed over.
Dispensed
Given to the subject at a visit.
Returned
Brought back to site or depot.
Quarantined
Held pending disposition after an exception.
Destroyed
Disposed with the destruction record attached.
Feature 03
Automated Site Resupply and PAR Triggers
Ship on what the site has actually used, not on a monthly review cycle.
- PAR levels per site - Minimum thresholds and reorder quantities defined for each site and kit type.
- Automatic manifests - When inventory dips below the minimum, a shipment manifest is generated for release.
- Consumption-driven - Because dispensing updates inventory in the same system, the trigger reflects the site's real position.
PAR Trigger
Site Inventory Below Threshold
Pune-04 Available Stock08 / PAR 12
Reorder quantity generated: 12 kits
Depot
Mumbai
Lot
L-2048
Release
Pending
Feature 04
Cold-Chain Temperature Excursion Workflow
Handle an excursion as a controlled process with a documented outcome.
- Excursion capture - Minimum and maximum temperature deviations recorded against the shipment or storage period.
- Automatic quarantine - Affected kits move to quarantined status and leave the dispensing pool.
- Logged disposition - Release back to inventory or destruction recorded with reason and decision-maker.
Temperature Excursion
Automatic Quarantine
2-8 C RangeMax 11.2 C
3 Kits Quarantined
Disposition required before release, return or destruction.
Review Excursion
Feature 05
Emergency Unblinding Workflow
Make treatment assignment reachable in a medical emergency without weakening the blind for anyone else.
- Dual authentication - The requester confirms identity through two factors before any assignment is revealed.
- Mandatory medical reason - The clinical justification is recorded at the point of unblinding.
- Instant notification - Sponsor, medical monitor and auditors are alerted with subject, requester and timestamp.
- Scoped disclosure - Only the requested subject assignment is revealed. Every other role and record remains blinded.
Emergency Unblinding
Scoped Disclosure
1
Authenticate Requester
Completed
2
Record Medical Reason
Required
3
Reveal Subject Assignment
Single Subject
4
Notify Sponsor and Auditor
Automatic
Use Cases
Where Teams Put Clinera RTSM to Work.
Four situations where allocation and supply have to hold up under pressure.
Balanced Allocation
Multi-Country Blinded Studies
Allocation balanced within strata across regions, with kit inventory tracked per depot and site.
Defensible Disposition
Cold-Chain Investigational Product
Temperature-sensitive product managed with excursion capture, automatic quarantine and recorded disposition.
Design Executed Faithfully
Adaptive and Stratified Designs
Minimization factors or shifting allocation ratios executed by the engine rather than managed manually.
Less Overage
Supply-Constrained Programs
Consumption-driven resupply keeps sites stocked without committing more drug than enrollment justifies.
Role Benefits
Role-Based Workflow and Benefits.
Four roles work the same system with deliberately different visibility, because who can see treatment assignment is the whole point.
RoleKey Capabilities in Clinera RTSMKey Benefit
Unblinded Pharmacist
View treatment-level kit detail, dispense against the allocation, manage site stock and returns.
Full supply visibility inside the boundary of the unblinded role.
Clinical Supply Manager
Set PAR levels, release shipment manifests, manage depot stock, expiry and excursion dispositions.
Resupply driven by consumption instead of periodic review.
Biostatistician
Configure or import the randomization schedule, define strata and minimization factors.
The design is executed as specified, with allocation records intact.
Principal Investigator
Randomize subjects and request emergency unblinding when clinical care requires it.
Access to assignment in an emergency without compromising the study.
Why Clinera RTSM
What Makes Clinera RTSM Different.
01
Blinding Enforced by the System
Role scoping applies to screens, exports and reports, so blind protection does not depend on remembering which file a blinded user should not open.
02
Supply Reads From Dispensing
Allocation, dispensing and inventory are one system, so resupply reflects what a site has actually used.
03
Exceptions Are Product, Not Process
Excursion quarantine and emergency unblinding are built workflows with mandatory fields, notifications and inspection-readable records.
Specifications
Platform and Compliance.
Clinera RTSM is deployed as part of the Clinera platform and inherits its security, audit and access-control model.
- Randomization Engines
- Permuted block, stratified block, dynamic minimization, adaptive allocation and list import.
- Kit Attributes Tracked
- Kit label, lot number and expiry date, with location held at depot and site level.
- Kit Status Model
- In inventory, reserved, dispensed, returned, quarantined and destroyed, with every transition recorded.
- Resupply Logic
- Site-level PAR minimums and reorder quantities, with shipment manifests generated on threshold breach.
- Emergency Unblinding
- Dual authentication, mandatory medical reason and immediate notification under 21 CFR Part 11 controls.
- Platform Integration
- Shares the study record with Clinera EDC and CTMS so allocation, visit data and operations stay aligned.
FAQ
Frequently Asked Questions.
How Long Does Study Build Take, and Can We Make Changes Mid-Study?+
Build time depends on design complexity. Straightforward parallel-group studies are faster than designs with minimization factors, cohorts and multi-depot supply. Mid-study changes are handled as configuration changes with scoped revalidation.
What Stops Someone With Access From Inferring Treatment Assignment?+
Role scoping is applied at the data layer, so blinded roles receive no treatment-revealing values in the interface, exports or reports. Kit selection is made by the system from available stock, and every allocation and unblinded access is logged.
What Happens if the System Is Unavailable When a Site Needs to Randomize?+
A documented contingency procedure is agreed during study setup. Fallback allocations are available only to defined roles and are reconciled into the system once service resumes.
How Do You Avoid Stock-Outs and Overage at the Same Time?+
PAR triggers respond to what a site has dispensed rather than a review cycle. Expiry is tracked per kit, and PAR levels can be tightened as enrollment uncertainty falls.
What Validation Work Falls on Our Team?+
Nirmitee supplies the study specification, configuration records and validation documentation, and supports UAT in a sandbox environment. Your quality team owns acceptance and SOPs around system use.
Next Step
Schedule a Clinera RTSM Demo.
Bring your randomization schema and one site's supply profile. We will configure the engine, PAR triggers and a few allocation scenarios on the call.