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IRT for Clinical Trials

IRT is the system your sites use to screen, enroll or randomize participants, assign treatment, and request drug, and the record of every one of those actions.

An IRT configured around your protocol and run by specialists, so your sites can get on with the trial.

What IRT Means in a Clinical Trial

IRT is where the protocol meets the site. A coordinator screens a participant, randomizes, dispenses a kit, or triggers resupply, and the system applies the rule your protocol set and records what happened.

That makes IRT a site tool and a sponsor control at the same time. The same system keeps allocation blinded where the design requires it, inventory accountable, and the audit trail complete.

  • Randomize or enroll: allocate participants to arms according to the scheme in your protocol, or enroll them directly in studies that do not randomize.
  • Dispense: assign kits at the visit and trigger resupply before a site runs short.
  • Record: every action time-stamped, with a history of who changed what, when, and why.
Solutions

What an IRT System Handles

Four connected areas — each one links down to a deeper page.

Participant Management

Screening, enrollment, randomization, visits, withdrawals, and unblinding in one system.

Treatment Assignment

Dynamic randomization, cohorts, strata management, and participant replacement.

Site Supply

Kit allocation, resupply, expiry dates, and inventory visibility at every site.

Oversight and Audit

On-demand reporting, dashboards, and audit trails that support inspection readiness.

Common IRT Challenges at the Site

  • Site workflows so involved that coordinators need retraining after every amendment.
  • Unblinding requests that have to be immediate and tightly controlled at the same time.
  • Configuration changes after go-live that queue behind a vendor change request.
  • Manual re-entry between IRT and the eCOA or EDC system.
  • A system built to the vendor’s template rather than to your protocol.
  • Screens and workflows that sites misread, turning into data errors.

How We Approach IRT

We run IRT on one unified platform, with specialists alongside it from study design through closeout.

One system, not a bolt-on

ClinPhone Pro covers randomization, participant, inventory, shipment, site, study, and user management with a single real-time view.

Built for the people using it

Guided visit registration, real-time validation, and simplified site workflows, designed with end-user feedback to reduce misreads and data errors.

Change without a change request

Self-service updates to inventory settings, recruitment controls, and operational parameters, without vendor intervention.

Interoperable by design

Integrations with eCOA, EDC, CTMS, labs, depot, and inventory systems, via an API-enabled architecture.

Supply that looks ahead

Forecast Order and our supply prediction algorithm anticipate each site’s supply needs, designed to prevent stock shortages at the visit.

Consultants beside the system

Clinical supply and randomization specialists who help set up your IRT supply and randomization settings, and review them as the study moves.

6,500+trials delivered
500+regulatory approvals supported
3M+participants randomized
100%on-time delivery
100+countries at first participant in
48%+pivotal Phase III (last 5 yrs)

Choosing an IRT Provider

Comparing IRT vendors, platforms, or software? Here is what sets us apart.

A 30-year IRT pioneer

Thousands of studies across all designs, therapeutic areas, and phases.

Consultants beside the platform

Clinical supply and randomization specialists who model your supply strategy and test it before you build, then keep reviewing it as the study moves.

Built for global trials

On-time systems for first participant in, across 100+ countries.

From first-in-human to pivotal

We support simple and complex studies across every phase. Pivotal Phase III programs made up more than 48% of our studies over the last five years.

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IRT FAQ

What does IRT stand for?

IRT stands for interactive response technology: the system sites use to screen, enroll or randomize participants, assign treatment, and manage drug supply at the site.

What's the difference between IRT and RTSM?

IRT is the interface layer sites use to interact with the system. RTSM is the broader discipline covering randomization and supply management together; the terms are often used interchangeably.

What about IVRS and IWRS?

IVRS and IWRS describe how a site reaches the system, by phone or by web. IRT is the umbrella term covering both.

What should I look for in an IRT provider?

A system configured to your protocol rather than a fixed template, workflows your sites can follow without constant retraining, integration with the rest of your eClinical stack, whichever vendors it includes, and specialists who support design as well as build.

Can an IRT system support adaptive or decentralized trials?

Yes. The platform is designed to support adaptive and complex designs, with native support for direct-to-patient and satellite site operations.

Can we change IRT settings mid-study without a change request?

Yes, for many changes. With ClinPhone Pro, your team updates inventory settings, recruitment controls, and operational parameters directly, without waiting on the vendor.

Talk Through Your IRT Requirements

Tell us about your protocol, and our specialists will help you find the right approach.