Randomization & Trial Supply Management (RTSM)

Manage enrollment, inventory needs, and reporting directly on the Fusion platform.

Randomization & Cohort Management Module

The Fusion Randomization & Cohort Management Module is fully configurable to the needs of your unique study. Get easy access to real-time enrollment details, notifications, and reporting with restrictions for unblinded and sensitive data (treatment or other).

Clinical Trial Material (CTM) Tracking Module

With Fusion’s CTM Tracking Module, your inventory tasks are completely centralized and automated. Our module not only tracks your investigational product or device, but also ancillary supplies, rescue medications, and turnkey ePRO devices.

Related Features: RTSM, IWRS, Cohort Management, IRT, CTM Tracking

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  • Pre-defined vs. real-time dynamic cohort activation and dose selection
  • Set reminders and track IP compliance via ePRO based on initial dose assignment, titration schedules and scheduled or ad hoc dose adjustments
  • Comprehensive enrollment management at study, site, and subject levels
  • Easy subject replacement management (e.g. enrolled but not treated, DLT assessment duration not met, etc.)
  • Eligibility requirements tailored to fit your protocol and inventory needs
  • Visualize enrollment progress with dashboards and configurable reports
  • Seamless integration of enrollment management (Randomization / Cohort Management) with inventory (CTM Tracking) and other relevant modules (e.g. Adjudication, ePRO)
Schedule a Demo for Your Biotech Study
  • Tracking of multi-use and single-use devices
  • Easy management of serialized and bulk inventory (lot or batch-based)
  • Shipment workflow tailored to fit your depot needs (e.g. Automated Packing Slips for shipments and returns with flexibility to support client and vendor-specific templates)
  • Comprehensive enrollment management at study, site, and subject levels
  • Easy subject replacement management
  • Eligibility requirements tailored to fit your protocol and inventory needs
  • Visualize enrollment progress with dashboards and configurable reports
  • Seamless integration of enrollment management (Randomization / Cohort Management) with inventory (CTM Tracking) and other relevant modules (e.g. Adjudication, ePRO)
Schedule a Demo for Your Device Study

Features and Benefits

Integrated Fusion RTSM Tools

Simple to complex randomization, fully integrated and linked to inventory. LEARN MORE

Real-Time Visualizations & Reports

Visualize everything with custom dashboards and reports. LEARN MORE

Manage Eligibility Criteria

Set study-specific eligibility criteria directly within Fusion. LEARN MORE

Randomization and Kit Lists Made Easy

From consulting to specifications, generation, and validation. LEARN MORE

Global Inventory Tracking

Centralized and automated inventory tracking and supply management. LEARN MORE

AI Driven Auto-Resupply

Supplies will be automatically restocked based on a multitude of factors. LEARN MORE

Global Depot Integration

Fusion RTSM is integrated with all major depots across the globe. LEARN MORE

Guided Support and Monitoring

Support and monitoring of all RTSM activities throughout the Study Lifecycle. LEARN MORE

 

Integrated Fusion RTSM Tools

Simple to complex randomization and cohort management, fully integrated and linked to inventory.

  • Central vs. Site-specific Randomization
  • Randomization / Kit List generation
  • Stratification and Cohort Management
  • Randomization caps at Study, Site & Strata-levels
  • Managing subject replacements
  • Eligibility requirements tailored to fit your protocol and ensure sufficient inventory
  • Visualize enrollment progress with dashboards and configurable reports

Real-Time Visualizations and Reports

Visualize everything with custom dashboards and reports.

  • Real-time reports on your RTSM & Inventory data
  • Generate real-time blinded and unblinded data, anytime
  • Immediate 24/7 access to your study data, global and local, throughout the Study Lifecycle
  • All underlying transaction data immediately loadable

Manage Eligibility Criteria

Set study-specific eligibility criteria directly within Fusion.

  • Subjects must meet eligibility requirements to be randomized
  • Minimum data entry requirements
  • Complex data comparisons
  • Minimum inventory requirements
  • Other intersecting module requirements

Randomization and Kit Lists Made Easy

From consulting to specifications, generation, and validation.

  • Independent randomization lists and kit lists for your unique study needs
  • Easily link Subjects to treatment arm or sequence
  • Overage based on total sites, enrollment rates and shipment lead times

Global Inventory Tracking

Centralized and automated inventory tracking and supply management.

  • Program-wide inventory levels, pooling, and forecasting
  • Depot integration, threshold monitoring, expiry management, and inventory returns
  • Automated site inventory requests, shipment reminders, quarantine management, and site-to-site transfers
  • Monitor dispensing activities on Site and Subject level, device and dosage accountability

AI Driven Auto-Resupply

Supplies will be automatically restocked based on a multitude of factors.

  • Current Inventory: Fusion accurately captures each Site’s current inventory including materials in transit and pending site receipt, upcoming expiries, and accountability or returns
  • Site Thresholds: Set resupply levels for buffer inventory or safety stock at the site-level are adjusted in real-time
  • Anticipated and Upcoming Needs: Calculated based on historical and scheduled activity

Global Depot Integration

Fusion RTSM is integrated with all major depots across the globe.

  • Depot management function is integrated directly into Fusion
  • Easily integrate your RTSM module with major global depots such as: Almac, Catalent, Fisher, PCI, and more!

Guided Support and Monitoring

Support and monitoring of all RTSM activities throughout the Study Lifecycle.

  • Dedicated RTSM specialist team and technology
  • Full walkthrough of workflow of Randomization and Inventory Management Modules
  • Axiom’s RTSM Team can help manage your depot and contracting
  • Available 24/7 to answer your questions in any time zone

RTSM and Fusion eClinical Suite

  • RTSM module accessible with Fusion single sign-on
  • Centralized Fusion database means all of your Subject data is in one place
  • Randomization/Cohort Management and CTM Tracking modules integrate seamlessly
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Talk to us about RTSM for your next study!

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