Nearly 20 years of randomization behind every build
- first IRT study in production
- 2006
- randomized studies supported
- 300+
- sponsors
- 100+
- investigator sites
- 8,000+
Figures include studies delivered by Clario and Bioclinica before they became part of Sitero. Source: Sitero study records, [2026].
LATEST UPDATES
Sitero Unveils the Latest Version of Mentor RTSM!
Enhanced self-service capabilities and advanced reporting.
Designed to empower clinical research teams, this cutting-edge technology streamlines trial management with greater efficiency, control, and real-time insights — ensuring seamless execution at every stage.
From approved spec to production in 2 to 4 weeks
Your study is assembled from pre-validated components instead of written as new code, so the build and test cycle fits in weeks.
2 to 4 weeks for standard designs
Specification approved
You sign off on randomization, supply, and visit rules. The clock starts here.
Configure
We set up your design from pre-validated components. No custom code.
Test with your team
Your team runs user acceptance testing (UAT) against the approved specification.
Live in production
Sites can randomize patients and dispense study drug.
More complex designs are scoped at kickoff, with a timeline built around your protocol.
Mentor RTSM Features
Sitero’s IRT/RTSM delivers unmatched speed, flexibility, and control with real-time inventory tracking, predictive resupply, and full support for complex study designs.
Agile No/Low Code Implementation
Out of the Box Support for Complex Protocol Designs
No/Low Code
Mid-Study Changes
Out of the Box Integration with EDC and eConsent
Transparent Realtime Actionable Reporting
Key Differentiators
Smart automation, advanced logistics, and total accountability—helping sponsors stay in control across global studies.
Designs we have already run
Your protocol is probably not the first of its kind for us. These design types, populations, and therapeutic areas all come from our IRT study history.
Study designs
- Phase I dose escalation
- Seamless Phase I/II and II/III
- Adaptive designs
- Platform trials
- Crossover
- Double-blind and double-masked
- Open-label extensions
- Medical device randomization
Populations
- Pediatric and adolescent
- Rare and ultra-rare disease
- Global, multi-region enrollment
Therapeutic areas
- Oncology
- Neurology and Alzheimer's disease
- Ophthalmology
- Pain
- Cardiovascular
- Endocrinology and metabolic
- Infectious disease and vaccines
- Respiratory
- Hematology
- 8,000 patients at 410 sitesin a single Phase III cardiovascular outcomes study
- 18 seamless-phase studiescombining Phase I/II or Phase II/III in one protocol
- 90+ indicationsfrom rare metabolic disorders to Alzheimer's disease
- 10+ yearsof continuous support on our longest-running studies
Includes studies delivered by [ACQUIRED COMPANY NAME] before it became part of Sitero.
Configuration versus custom code
Protocols change after go-live. How your IRT is built decides how quickly it can follow.
| What you are comparing | Custom-coded IRT | Mentor RTSM |
|---|---|---|
| How your study is built | New code written for your protocol | Configured from pre-validated components |
| Standard design to production | Depends on development and testing capacity | 2 to 4 weeks from approved specification |
| Mid-study amendment | A code change, then development and retesting | A configuration change, with no custom code |
| Complex designs | Built case by case | Master protocols, multi-cohort studies, dynamic minimization, and direct-to-patient supply supported out of the box |
| EDC connection | A custom integration for each study | Standard APIs to any EDC, or embedded in Mentor EDC |
Trusted by large pharma and the CROs that run their trials
A top-5 global pharma company has consolidated 80+ studies onto Mentor RTSM over a 10+ year partnership.
Read the top-5 pharma case studyCROs choose our IRT for their sponsors' studies too. More than 140 studies in our history were delivered through 15+ CROs, from global full-service CROs to specialty partners.
"The platform is flexible enough for our most complex protocols but still easy for sites to use, which is critical."
Why Mentor RTSM?
Configurable for complex protocols
Built for mid-study amendments
Connected to your trial stack
Questions RTSM buyers ask us
How fast can our study go live?
Standard designs go from approved specification to production in 2 to 4 weeks. More complex designs are scoped at kickoff, with a timeline built around your protocol.
What happens when our protocol is amended mid-study?
Amendments are made by changing the configuration, not by writing new code, and the change is tested before it reaches your sites.
Does Mentor RTSM work with our EDC?
Yes. It connects to any EDC through standard APIs, or runs inside Mentor EDC so site staff randomize and enter data on one screen.
Can we use Mentor RTSM on its own?
Yes. Many of our studies use Mentor RTSM as a standalone system, with the sponsor or its CRO running the rest of the trial.
Have you run a design like ours?
Probably. Our history covers dose escalation, seamless-phase, adaptive, platform, and pediatric studies. See the designs we have run, or bring your protocol to a demo.
See how your protocol would be configured
Request a demo and bring your protocol or synopsis. We will walk through how Mentor RTSM would set up your randomization and supply.
Request a demoIRT/RTSM Resources
Check out our latest blog posts on clinical supply strategies. More tools and updates coming soon to help you get the most from Mentor RTSM.
Biomarker-driven oncology trials enroll slowly because eligibility depends on a chain of steps — tissue procurement, sample shipment, lab processing, result communication, and site decision — each owned by a [...]
Explore how Sitero’s RTSM platform enabled a top 5 pharma company to streamline their randomization and supply management across complex global studies in our latest case study:
