Randomization & Trial Supply Management (RTSM)

Cloudbyz Randomization & Trial Supply Management (RTSM) is a cloud-based solution designed to streamline and automate the randomization and supply logistics of clinical trials. Built with an integrated Interactive Web Response System (IWRS), it supports simple to complex randomization schemes and ensures accurate investigational product distribution across global sites. The platform enhances trial efficiency, maintains scientific integrity, and ensures compliance with regulatory standards.

Features

• Study Build: Configure studies based on protocol requirements including phase, cohorts, therapeutic area, and eligibility criteria.
• Cohort Management: Open and close cohorts dynamically based on enrollment needs.
• Randomization: Supports simple, blocked, stratified, and adaptive randomization methods with direct linkage to site inventory.
• IP Orders Management: Automates inventory requests when thresholds are reached and enables manual ordering as needed.
• IP Inventory Management: Centralized tracking of investigational product inventory, including quarantine and shipment reminders.
• IP Accountability & Reconciliation: Tracks kit and product status across sites for centralized oversight and reconciliation.
• Shipment Management: Monitors shipments from order to delivery and return, including temperature-sensitive products.
• Real-Time Analytics: Dashboards and reports for recruitment, inventory, and supply chain performance.

Capabilities

• Integrated IWRS: Ensures accurate and blinded treatment assignment while maintaining protocol compliance.
• Automated Supply Forecasting: Predicts inventory needs based on enrollment and consumption rates, triggering resupply actions.
• Blinding and Unblinding Controls: Maintains trial integrity with secure, documented unblinding procedures.
• Patient Tracking: Monitors enrollment, treatment allocation, and supply usage across sites.
• Regulatory Compliance: Supports GCP, 21 CFR Part 11, and other global standards with audit trails and secure data handling.
• Scalable Integration: Connects with CTMS, EDC, and other systems via open APIs for unified trial management.

Benefits

• Enhances trial efficiency through automation and centralized control.
• Reduces manual errors and operational costs.
• Improves data integrity and real-time visibility into trial logistics.
• Ensures continuous treatment availability and minimizes stockouts.
• Supports complex trial designs including decentralized and hybrid models.
• Facilitates regulatory compliance and inspection readiness.