Randomization
Technology supporting any methodology, from simple to complex, standard to novel.
Randomization and Trial
Supply Management
RTSM is the technology and process that enrolls or randomizes participants and keeps the right supply in the right place for every visit, from first participant in to database lock.
Right-fit RTSM, delivered by experts, so your randomization matches your protocol and your supply keeps up with it.
What RTSM Means 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. Not every study randomizes. Enrollment-only studies use the same system to register participants and supply them.
Get either one wrong and the other suffers. A randomization scheme that outpaces depot stock stalls enrollment; supply planning that ignores the scheme wastes drug. RTSM keeps them aligned.
- Randomization or enrollment: assign participants to arms across any design, simple to adaptive, or enroll them directly when the study does not randomize.
- Trial supply: forecast, predict, resupply, and track drug so participants stay on treatment.
- One connected view: enrollment or randomization, inventory, and logistics in a single platform.
Solutions
The Four Capabilities Behind RTSM
Trial Supply Management
Inventory management keeps enough stock at shipping locations to reach your sites. Medication management makes sure each participant has the right treatment in hand at the right time, without it expiring during use.
Clinical Study Management
Site and clinical team management on one scalable system, so each site and study role sees and does what it should.
Data Integrity
Solutions designed to safeguard data and give each user real-time access at the right level of detail, for confident decisions.
Common RTSM Challenges in Clinical Trials
- 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.
- Blinding breaks that compromise data integrity.
- Mid-study amendments that force a change to the design after go-live.
- Cohorts that cannot be opened when needed, or new ones that cannot be added when the protocol requires them.
- Study teams without the right data, at the right level, to make quick and informed decisions.
How We Approach RTSM
We pair one unified RTSM platform with specialists who help you design the right approach before you build it.
Unified platform
ClinPhone Pro covers randomization, participant, inventory, shipment, site, study, and user management with a single real-time view.
Predictive supply
Forecast Order and our supply prediction algorithm anticipate future supply needs, designed to reduce stock shortages.
Expert delivery
An embedded team supports you from design through closeout: project manager, solution designer, integration specialist, data management, and support, plus clinical supply and randomization consultants who help shape the strategy before the build.
Interoperable by design
Integrations with eCOA, EDC, CTMS, labs, depot, and inventory systems, via an API-enabled architecture.
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 RTSM Solutions
Five ways to run RTSM with us
ClinPhone Pro
Next-generation RTSM platform, configurable for trials of any complexity.
ClinPhone Pro Core
Ready-to-deploy RTSM on proven configurations, for studies that do not need heavy customization.
Clinical Supply Management
Supply strategy, forecasting, and randomization consultancy, plus IRT supply training.
ClinPhone Pro + Clin'Form
RTSM and eCOA in one connected solution (Clin'Form via the Kayentis partnership).
Clinical Delivery Services
End-to-end design, integration, validation, deployment, and support.
Choosing an RTSM Provider
Searching for an RTSM provider, vendor, or the best RTSM 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.
Depth where it counts
More than 48% of studies over the last five years were pivotal Phase III programs.
Expert POV
RTSM FAQ
What does RTSM stand for?
RTSM stands for randomization and trial supply management: the technology and process for assigning participants to treatment arms, or enrolling them in studies that do not randomize, and managing the drug supply those assignments require.
What’s the difference between RTSM and IRT?
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.
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 should I look for in an RTSM provider?
A platform that fits your protocol rather than forcing you to fit it, 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 RTSM 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 the supply strategy or study settings mid-study?
Yes. 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 the RTSM Cluster
Talk Through Your RTSM Strategy
Tell us about your protocol, and our specialists will help you find the right approach.