Randomization
Any methodology, simple to complex, standard to novel, with dynamic randomization, cohorts, strata management, and participant replacement.
IRT and RTSM for Clinical Trials
The system your sites use to enroll or randomize participants and dispense treatment, and the supply management behind it that keeps the right drug at every visit, from first participant in to database lock.
Right-fit IRT and RTSM, configured around your protocol and run by specialists, so your sites can get on with the trial.
What IRT and RTSM Mean in a Clinical Trial
RTSM brings two connected jobs into one system: assigning participants without introducing bias, and managing the trial supply each assignment creates demand for. IRT is where that system meets the site. A coordinator screens a participant, randomizes, dispenses a kit, or triggers resupply, and the system applies the rule your protocol set.
Most teams use the two terms interchangeably. Get either job wrong and the other suffers: a randomization scheme that outpaces depot stock stalls enrollment, and supply planning that ignores the scheme wastes drug.
- Randomize or enroll: assign participants to arms across any design, simple to adaptive, or enroll them directly when the study does not randomize.
- Supply: forecast, dispense, and resupply so each site has the right kit before a participant arrives.
- Record: every action time-stamped, with a history of who changed what, when, and why.
Solutions
The Four Capabilities Behind IRT and RTSM
Each capability links to a deeper page.
Trial Supply Management
Enough stock at shipping locations to reach your sites, and the right treatment in each participant’s hands at the right time, without it expiring during use.
Clinical Study Management
Screening, enrollment, visits, withdrawals, and unblinding on one scalable system, so each site and study role sees and does what it should.
Data Integrity
On-demand reporting, dashboards, and audit trails that support inspection readiness, with real-time access at the right level of detail.
Common IRT and RTSM Challenges
- Imbalanced groups when stratification factors aren’t planned well, weakening statistical power.
- Stock-outs and overage when supply forecasting drifts from the randomization scheme.
- Allocation errors or delays at the site that stall enrollment.
- Unblinding requests that have to be immediate and tightly controlled at the same time.
- Mid-study amendments that queue behind a vendor change request and send coordinators back to training.
- Cohorts that cannot be opened when needed, or new ones that cannot be added when the protocol requires them.
- Manual re-entry between IRT, eCOA, and EDC, and site screens that are easy to misread, both turning into data errors.
How We Approach IRT and RTSM
We run IRT and RTSM on one unified platform, with specialists alongside it from study design through closeout.
One unified platform
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.
Predictive supply
Forecast Order and our supply prediction algorithm anticipate each site’s supply needs, designed to reduce stock shortages at the visit.
Expert delivery
An embedded team from design through closeout, plus clinical supply and randomization consultants who shape your strategy before the build and review it 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)
Our IRT and RTSM Solutions
Five ways to run IRT and RTSM with us. Each card routes to its product page.
ClinPhone Pro
Next-generation RTSM/IRT platform, configurable for trials of any complexity.
ClinPhone Pro Core
Ready-to-deploy RTSM/IRT on proven configurations, for studies that do not need heavy customization.
Clinical Supply Management
Supply strategy, forecasting, and randomization consultancy, including IRT configuration decisions and supply training.
ClinPhone Pro + Clin'Form
IRT, RTSM, and eCOA in one connected solution (Clin’Form via the Kayentis partnership).
eClinical Delivery Services
End-to-end design, integration, validation, deployment, and support.
Choosing an IRT or RTSM Provider
Comparing IRT and RTSM vendors, platforms, or software? Here is what sets us apart.
A 30-year RTSM 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.
Expert POV
IRT and RTSM FAQ
Are IRT and RTSM the same thing?
In practice, mostly, and the terms are often used interchangeably. Where teams draw a line, IRT is the interface layer sites use to interact with the system, and RTSM is the broader discipline covering randomization and supply management together.
How does randomization connect to trial supply?
Your randomization scheme drives demand at each site and depot. Aligning the two helps you avoid stock-outs and keep participants on treatment.
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 or RTSM provider?
A system configured to your protocol, workflows your sites can follow without constant retraining, proven delivery across your phase and therapeutic area, integration with the rest of your eClinical stack, whichever vendors it includes, and specialists who support design as well as build.
Can IRT and RTSM support adaptive or decentralized trials?
Yes. ClinPhone Pro is designed to support adaptive and complex designs, with native support for direct-to-patient and satellite site operations.
Can we change supply or study settings mid-study?
Yes, for many changes. With ClinPhone Pro, your team updates inventory settings, recruitment controls, and operational parameters directly, without a change request. Forecast Order predicts upcoming shipment needs in one click, so supply can follow the study as it changes.
Explore Related Pages
Talk Through Your IRT and RTSM Needs
Tell us about your protocol, and our specialists will help you find the right approach.