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RTSM

Randomization and trial supply management with adaptive design, cohort escalation, and real-time reporting for clinical studies of any complexity.

Solution by S-Clinica
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Overview

S-Clinica's RTSM (Randomization and Trial Supply Management) is a comprehensive IRT solution designed to support clinical trials of any complexity. Built for biotech and pharmaceutical sponsors who demand flexibility and speed, the platform combines advanced randomization capabilities with robust trial supply management tools — all within a single, integrated system trusted by top-tier biotech organizations.

The RTSM module is part of S-Clinica's broader ClinVision platform, which encompasses clinical supply forecasting, personalized medicine, drug and supplies management, direct-to-patient logistics, supplies return and destruction, data transfer and integrations, and IRT for veterinary clinical trials.

Advanced Setup and Configuration

  • Unique setup approach designed to minimize configuration time
  • Very short setup timelines to accelerate study start-up
  • 100% flexible architecture capable of supporting studies of any complexity

Randomization Capabilities

  • Supports any type of randomization algorithm, accommodating diverse study designs
  • Specific treatment allocation plans can be configured to meet unique protocol requirements
  • Adaptive design support for studies requiring dynamic protocol adjustments

Study Complexity and Customization

  • No impact on timelines regardless of study complexity or scale
  • No limitations on the types of studies that can be managed
  • Study-specific functionalities can be implemented to address unique protocol needs

Cohort and Dose Escalation Management

  • Powerful and flexible cohort management capabilities
  • New cohorts can be introduced without requiring a protocol amendment, saving time and reducing administrative burden
  • Supports dose escalation studies with dedicated management tools

Change Management and Operational Efficiency

  • Smooth and prompt change management processes to handle protocol amendments with minimal disruption
  • Advanced module specifically designed for open-label studies management
  • Facilitated user experience to reduce training burden and improve site compliance

Reporting, Alerts, and Accessibility

  • Real-time reports and alerts to keep study teams informed at all times
  • Mobile version available, enabling access to the platform from any device

S-Clinica's RTSM is positioned as a vendor of choice for complex clinical projects, offering seamless integration with the broader ClinVision ecosystem including data transfer and third-party integrations, making it suitable for sponsors seeking a scalable and adaptable IRT solution across a wide range of therapeutic areas and trial designs.

Meta

Domain
Clinical Trial Management
Subdomain
Randomization & Trial Supply Management
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11GxP