Randomisation & Trial Supply Management (RTSM/IRT)
Robust, validated randomisation and drug supply management engineered for complex clinical trial designs. From simple block randomisation to adaptive multi-arm studies, our RTSM platform ensures protocol-compliant treatment allocation, real-time inventory visibility, and optimised supply chain logistics — all within a single, integrated system.
Intelligent Randomisation & Supply Management
Our RTSM/IRT platform delivers a comprehensive, end-to-end solution for treatment randomisation and clinical drug supply management. Purpose-built for the complexities of modern trial designs, the system supports everything from straightforward parallel-group studies to sophisticated adaptive, multi-arm, and basket trial architectures.
With real-time inventory tracking across global depot and site networks, predictive supply forecasting, and seamless integration with our EDC, CTMS, and ePRO modules, the platform ensures that the right treatment reaches the right patient at the right time — while maintaining complete blinding integrity and a fully auditable trail of every randomisation and dispensing event.
Comprehensive RTSM Feature Set
Six integrated capability areas working together to deliver protocol-compliant randomisation, optimised drug supply, and complete trial supply chain oversight.
Flexible Randomisation
Block randomisation, stratified randomisation, minimisation, adaptive designs, and re-randomisation support for simple through complex protocols.
Drug Supply Management
Real-time inventory tracking, automated resupply triggers, expiry management, and depot-to-site distribution with complete chain-of-custody visibility.
Supply Forecasting
Predictive demand modelling, waste reduction analytics, and scenario planning for optimal supply chain management and cost efficiency.
Blinding Management
Robust blinding integrity controls, controlled emergency unblinding procedures, and access-controlled treatment assignment reports.
Multi-Channel Access
Web-based and IVR/IVRS access for site personnel with 24/7 availability and fail-safe redundancy ensuring uninterrupted service.
EDC Integration
Seamless bi-directional data flow with our EDC platform for automated eligibility verification and visit-driven dispensing workflows.
Built for Every Role in the Trial
Our RTSM platform is designed with role-specific workflows and dashboards, ensuring every stakeholder has the tools and visibility they need.
Sponsors
Complete oversight of randomisation integrity and supply chain performance across your entire programme.
- Protocol compliance assurance
- Supply chain visibility & analytics
- Blinding assurance & audit readiness
- Real-time enrolment monitoring
- Treatment allocation oversight
CROs
Scalable, multi-study management tools with centralised supply oversight and rapid study configuration.
- Multi-study scalability
- Centralised supply oversight
- Rapid protocol configuration
- Cross-study reporting dashboards
- Template-driven study setup
Site Teams
Intuitive, streamlined workflows that simplify randomisation and dispensing at the point of care.
- Simple randomisation workflows
- Real-time kit availability view
- 24/7 web and IVR access
- Clear dispensing instructions
- Automated eligibility checks
Integrated with Your eClinical Ecosystem
Our RTSM platform operates as a fully integrated module within the MTK eClinical suite. Bi-directional data flows eliminate manual reconciliation, reduce errors, and provide a single source of truth across all trial operations.
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EDC Integration
Automated eligibility verification from eCRF data, visit-driven randomisation triggers, and real-time data synchronisation between EDC and RTSM.
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CTMS Integration
Site activation status feeds into supply allocation, enrolment milestones drive resupply triggers, and site performance data informs supply planning.
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ePRO Integration
Patient-reported outcome data supports treatment compliance monitoring, adaptive dosing decisions, and visit schedule alignment with dispensing events.
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Analytics Integration
Unified analytics layer aggregates randomisation metrics, supply chain KPIs, and forecasting data into real-time dashboards and automated reports.
Why Choose MTK for RTSM
Deep domain expertise, a unified technology platform, and unwavering commitment to regulatory excellence set our RTSM solution apart.
Domain Expertise
Our team brings years of clinical trial randomisation experience across all phases and therapeutic areas, ensuring your protocol is configured correctly from the start.
Unified Platform
RTSM operates within our integrated eClinical suite, sharing a common data layer with EDC, CTMS, ePRO, and Analytics for seamless trial operations.
Regulatory Ready
GAMP 5 validated, 21 CFR Part 11 compliant, and GDPR-ready with complete audit trails, electronic signatures, and inspection-ready documentation.
24/7 Support
Round-the-clock technical and operational support ensuring your randomisation and supply systems are always available when sites need them most.
See RTSM in Action
Schedule a personalised demonstration to discover how our RTSM/IRT platform can streamline your randomisation workflows, optimise drug supply logistics, and deliver complete trial supply chain visibility from depot to patient.