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Sponsors with complex designs
Adaptive dosing, titration or several cohorts in one protocol.
Healthcare / Clinical Trials IRT
Clinical trials IRT that randomizes, dispenses and resupplies correctly
A wrong randomization, a site out of stock or an unblinding that cannot happen at night puts a study and its participants at risk. Agnotic Technologies builds IRT and RTSM software that randomizes to your protocol, keeps the blind, and moves the right kits to the right sites before they are needed.
Blind kept
Kit numbers that never reveal the arm
Around the clock
Emergency unblinding for investigators
Depot to site
Shipments, receipts and excursions tracked
Trusted by global innovators
Industry Overview
What is IRT in clinical trials?
Interactive response technology (IRT), also called RTSM, is the system that randomizes participants, assigns blinded kits at each visit and manages study drug supply from depot to site. Agnotic Technologies builds clinical trials IRT with tested randomization, emergency unblinding, resupply rules, temperature excursion handling and integration with your EDC.
Industry Challenges
Where does IRT go wrong mid-study?
IRT errors are expensive because they reach participants, kits and the analysis at the same time.
Randomization errors: a stratification factor or block set up wrongly and found only after participants are assigned.
Stockouts and waste: resupply rules that ship too late for a fast site or too much to a slow one.
Blind leaks: a report, an email or a kit number pattern that lets blinded staff infer the treatment arm.
Unblinding delays: an investigator who cannot unblind one participant quickly when there is a medical emergency.
Excursion kits dispensed: kits from a shipment that went out of range assigned before anyone reviewed them.
Two versions of the truth: IRT and EDC disagreeing on randomization or visit dates.
Decision table
Which randomization method fits your protocol?
Your statistician chooses the method; the IRT has to carry it out exactly. This is how each common method changes what we build and test.
| Method | How it assigns | Typically used when | What the IRT must handle |
|---|---|---|---|
| Simple | Each participant assigned independently from a list | Large trials where chance imbalance is acceptable | A pre-generated list, consumed in order |
| Permuted block | Assignments balanced within blocks of a set size | Arms should stay balanced throughout enrollment | Block sizes hidden from blinded users |
| Stratified block | Separate block lists per combination of stratification factors | A few known factors, such as site or disease stage, affect outcome | Correct factor entry, with corrections controlled and logged |
| Minimization | Assignment that reduces imbalance across several factors as each participant enrolls | Many factors or small strata | The algorithm, its random element and a full log of each decision |
Our Approach
How is the blind protected inside the IRT?
Blinding is a design property of the whole system, not one screen. These are the controls we build.
Blinded and unblinded roles
Only named unblinded roles, such as a pharmacist or supply manager, can see treatment information.
Kit numbers without meaning
Kit numbers are drawn from a randomized list, so their sequence never points to an arm.
Blind-safe outputs
Reports, emails and data sent to the EDC are checked so they carry no treatment information for blinded users.
Unblinding for one participant
Emergency unblinding reveals one participant's treatment only, to the requesting investigator, and is logged.
Capabilities
What does an IRT system do?
Modules we build for an IRT or RTSM, configured from your protocol and supply plan.
Randomization
The method your statistician specifies, run from a controlled list or algorithm, with stratification checks.
Kit dispensing
The right kit type assigned at each visit, matched to dose, titration and site stock.
Resupply and forecasting
Trigger and resupply levels per site, with shipments raised before stock runs short.
Depot and shipment tracking
Depot stock, shipments, receipts and expiry dates, with lots released for use by an unblinded role.
Temperature excursions
Kits from an out-of-range shipment or storage period quarantined until a reviewer decides on their use.
Emergency unblinding and accountability
Investigator unblinding at any hour, plus dispensing, returns and destruction records per kit.
How It Works
How does emergency unblinding work in the IRT?
The path we build for an emergency unblinding. It must work at any hour, and it must reveal no more than one participant's treatment.
Investigator signs in
The investigator authenticates with their own account; the action is limited to their site's participants.
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1
Participant and reason
The investigator selects the participant and records the reason, such as a medical emergency.
02
2
Confirmation
The system asks the investigator to confirm, so an unblinding is never done by accident.
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3
Treatment revealed
The treatment for that one participant is shown to the investigator only, and other assignments stay hidden.
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4
Notifications
The sponsor's agreed contacts are told that an unblinding happened, without the treatment in the message to blinded staff.
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5
Record kept
Who unblinded, when, for which participant and why is stored in the audit trail for the trial records.
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6
Engineering Stack
Technologies behind an IRT
The interfaces, integrations and platforms behind the IRT and RTSM software we build.
Interfaces
Web application for sites and depotsMobile-friendly dispensing screensBarcode and scanner support
Integrations
EDC and CDMSDepot and courier systemsTemperature logger data files
Backend
Node.jsPythonPostgreSQL
Infra
AWSAzureMulti-region failover for around-the-clock access
Measured Impact
What does the supply manager see?
Measures we build into the supply dashboard, agreed with your clinical supply lead.
Site stock
Kits on hand against trigger levels
By site and kit type.
Expiry
Kits nearing expiry
So they are used, swapped or replaced in time.
Quarantine
Kits awaiting excursion review
With the shipment or storage event behind each one.
Shipments
In transit and overdue
From each depot to each site.
My Lauren Maternal Health Platform | Built by Agnotic
A HIPAA-ready maternal health platform enabling remote patient monitoring, care coordination, and personalized engagement from pre-pregnancy through postpartum.
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A women’s health product experience focused on guided care journeys, education, and compliance-aware workflows to support long-term engagement.
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Use Cases
Who builds an IRT with us?
Teams whose randomization or supply needs go beyond a standard configuration.
02
Clinical supply teams
Forecasting and resupply rules matched to their own depots.
03
CROs
IRT capability across several sponsors' studies.
04
Cell and gene therapy programs
Patient-specific products with tight chain of custody.
05
Academic trial units
Randomization services for investigator-led trials.
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IRT for startups
Clinical trials IRT for startups building a randomization or supply product or service.
Integrations
Systems an IRT connects to
The systems that receive randomization and dispensing data from the IRT, or send it supply events.
Randomization and dispensing data
EDC or CDMS
Visit schedule
eCOA
Shipments
Depots and couriers
Excursions
Temperature loggers
Sites and enrollment
CTMS
Randomization lists
Unblinded statistics team
Self-assessment
Which scenarios should be tested before IRT go-live?
The failure points we write test scripts for with your supply and statistics leads. Your validation plan decides the final set.
Compliance-First Development Services Backed by Global Standards
We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.
Health Insurance Portability and Accountability Act
Protect PHI with privacy-first architecture, encrypted storage and transmission, and strict access controls.
General Data Protection Regulation
Implement lawful consent flows, data minimization, and secure processing for global data privacy.
Our Edge
Why Global Leaders Choose Us
We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.
Enterprise-Grade Security
We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.
High-Performance Scaling
Our architectures are built to handle massive data loads and user bases, keeping performance steady whether you're serving ten or ten million.
Accelerated Time-to-Market
Using our suite of internal tools and proven frameworks, we reduce development cycles and get your product to market 40% faster.
Embedded AI Integration
Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.
Engagement Model
How does an IRT build work?
How to build clinical trials IRT from your protocol and supply plan. Timing depends on scope, and we agree a fixed first release on the scoping call.
01
Scoping call
We agree the design, the randomization method, the supply chain and the systems to connect.
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Specification
Randomization, dispensing, resupply and unblinding rules written up for sign-off by your statistics and supply leads.
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Fixed-scope first release
Randomization, dispensing and emergency unblinding for one study, tested against the scenario checklist.
04
Supply and integration
Depots, resupply, excursions and EDC integration added and tested with your supply team.
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Validation and study support
Test evidence for your validation package, then mid-study changes under change control and support under agreed terms.
Facts and sources
Which rules shape IRT and RTSM software?
Short facts behind randomization, blinding and drug supply software, each linked to its primary source.
Under 21 CFR 314.126(b)(4), an adequate and well-controlled study assigns patients to treatment and control groups in a way that minimizes bias, and in a concurrently controlled study assignment is ordinarily by randomization, with or without stratification.
Source: 21 CFR 314.126(b)(4) (eCFR)ICH E6(R3) says that in an emergency the investigator should be prepared and capable from the start of the trial to unblind without undue delay, and should promptly document and explain any premature unblinding to the sponsor.
Source: ICH E6(R3), section 2.11 (ICH)For blinded trials, ICH E6(R3) asks the sponsor for a mechanism that lets the investigator rapidly identify the product in a medical emergency while protecting the treatment assignment of the other participants.
Source: ICH E6(R3), section 3.15.2(d)(ii) (ICH)Under 21 CFR 312.57(a), a sponsor must keep records of the receipt, shipment or other disposition of the investigational drug, including the investigator it was shipped to and the date, quantity and batch or code mark of each shipment.
Source: 21 CFR 312.57(a) (eCFR)Under 21 CFR 312.62(a), an investigator must keep adequate records of the disposition of the drug, including dates, quantity and use by subjects, and return or otherwise dispose of unused supplies when the investigation ends.
Source: 21 CFR 312.62(a) (eCFR)
Voice of success
We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.
“I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly.”
Aaron Phelan
Founder, Benchmark
“Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective.”
John Pasmore
Founder, Latimer
“Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together.”
Kim Smith
Founder, My Lauren
Related services
Related clinical trial and supply services
Pages for the systems and teams around randomization and supply.
Clinical trial management software (CTMS)
The operational layer: sites, subjects, visit schedules, enrollment and monitoring.
Life sciences and clinical trial software development
The wider view of study software: recruitment, eConsent, participant apps and Part 11 controls.
Pharmaceutical software development
Software for pharma operations beyond the trial itself.
HIPAA requirements for software teams
The safeguards we build into every system that holds patient data.
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Cross-Industry Reach
The Same Engineering Patterns, Across Other Industries
The technical patterns behind this platform translate naturally into adjacent verticals.
Frequently Asked Questions
In practice, yes. IRT (interactive response technology) and RTSM (randomization and trial supply management) name the same kind of system: randomization, kit dispensing and drug supply. Older systems ran by phone (IVRS) or web (IWRS); the IRTs we build are web based.
An unblinded statistician on your side or at a service provider, following your randomization specification. We build a controlled process to load and verify the list, and blinded users never see it.
Kits from an out-of-range shipment or storage period are quarantined automatically so they cannot be dispensed. A named reviewer records whether they can be used, based on the stability data your team holds, and the decision is logged per kit.
Yes. Randomization and dispensing events go to the EDC through its API or an agreed transfer, with treatment information left out for blinded users. Failed transfers are retried and reported.
With HIPAA-ready engineering: the IRT holds as little personal data as possible, usually participant numbers and the factors needed for randomization, with encryption, role-based access and audit trails. Agnotic signs a business associate or data processing agreement where needed.
The randomization method and design complexity, the number of kit types and depots, resupply logic, integrations with EDC and couriers, mid-study changes and the validation evidence your quality team needs. We describe these drivers on the scoping call rather than quote a price before it.
It depends on scope. We agree a fixed first release on the scoping call, usually randomization, dispensing and emergency unblinding for one study, and give you a timeline for that release.
AI tools help our engineers draft code and tests. An engineer reviews every change, and every release is tested against the requirements and test scripts your validation team signs off.
Industries