The Challenge

• Need for centralization: Lacked a unified system for managing randomization and trial supply processes across studies
• Protocol-specific demands: Required flexible randomization methods, including block and stratified models
• Integration complexity: Needed real-time connectivity between EDC and RTSM for seamless data flow
• Inventory oversight: Inadequate visibility into kit levels, leading to inefficiencies in supply chain management
• Operational delays: Manual processes and data silos were slowing trial execution and decision-making

The Solution

• Real-time subject randomization: Integrated Cloudbyz RTSM with Cloudbyz EDC to enable immediate, protocol-compliant randomization and data sync
• Advanced randomization logic: Supported complex randomization strategies including block, stratified block, and adaptive models
• Supply chain optimization: Configured threshold-based notifications for investigational product (IP) resupply and centralized tracking of kit inventory
• Seamless data export: Enabled trial teams to extract randomization and supply chain data in standardized formats (CSV, PDF)
• Integrated ecosystem: Leveraged Cloudbyz CTMS for holistic trial oversight, combining operational, data, and supply visibility
• Single source of truth: Unified data flows eliminated redundancy and fostered better coordination across trial functions

The Results

• Unified trial supply system: Consolidated all current and future trials under one robust RTSM platform
• Operational acceleration: Reduced trial start-up times by synchronizing supply readiness with enrollment rates
• Real-time visibility: Enabled on-demand access to subject status, supply consumption, and resupply projections
• Improved compliance and decision-making: Gave clinical teams reliable, up-to-date information to guide operational planning
• Scalability for growth: Positioned the organization to handle a broader portfolio of trials with consistent quality and speed