Randomization & Trial Supply Management

The Randomization & Trial Supply Management (RTSM) solution by Cloudbyz is designed to meet the specific requirements of clinical studies. It features an integrated Interactive Web Response System (IWRS) that efficiently manages both simple and complex randomization schemes, including stratifications and multi-arm studies. The system also handles comprehensive trial supply management tasks such as Investigational Product (IP) accountability, centralized inventory tracking, threshold management, automated orders, and notifications.

Key Features:

• Study Build: Configure and visualize studies according to protocol requirements, with easy access to details like phase, type, cohorts, therapeutic area, indication, outcomes, and eligibility.
• Cohort Management: Fully configurable features allow for easy management of cohorts, enabling opening and closing based on enrollment needs.
• Randomization: Conduct fast and accurate subject randomization linked directly to site inventory, supporting simple, blocked, and stratified randomizations.
• IP Orders Management: Tracks site inventory and sends electronic requests for additional supply when inventory falls below a minimum level, with options for manual order placement.
• IP Inventory Management: Offers automated and centralized inventory tracking, including shipment reminders and quarantine management.
• IP Accountability & Reconciliation: Centralized management of IP accountability and reconciliation, providing kit and IP status for each site throughout the study.
• Shipment Management: Tracks shipments from orders to delivery and returns, ensuring uninterrupted drug supply.
• Investigator Portal: A single platform for clinical research sites to complete eCRFs, report protocol deviations, maintain electronic Investigator Site Files, and communicate with stakeholders.
• Patient Portal: Integrates seamlessly for ePRO, eConsent, patient information, education, lab reports, and screening results.
• Real-time Analytics: Offers customizable reports and dashboards to track metrics such as enrollment numbers and inventory levels.
• Patient Screening & Dispense Management: Manages patient screening caps and drug dispensing with automated instructions to minimize mis-dispensing risks.
• Emergency Unblinding: Provides secure code-breaking functionality with authorization setup and data freezing options.
• Subject Replacement: Facilitates easy subject replacement and re-randomization for withdrawals and disqualifications.
• Real-time Recruitment Notifications: Provides real-time recruitment and randomization notifications to sites, CROs, and sponsors.
• Automatic Inventory Monitoring: Manages inventory automatically based on subject enrollment and treatment, adjusting supply processes as needed.
• Workflow and Notifications: Configurable automations and notifications offer a scalable solution throughout the clinical research cycle.