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Randomization and Trial Supply Management (RTSM)
GAJA RTSM (Globally Accessible RTSM with Justified Accuracy) is a secure digital platform that manages patient randomization, drug allocation, and inventory tracking in clinical trials. It ensures accurate treatment assignment, supply chain efficiency, and compliance with study protocols.
Why Choose GAJA RTSM for Your Clinical Trials?
- ✔ Accurate Randomization Eliminates manual errors in patient allocation.
- ✔ Optimized Supply Management Tracks drug inventory, shipments, and resupplies in real time.
- ✔ Regulatory Compliance Fully adheres to ICH-GCP and 21 CFR Part 11 standards.
- ✔ Real-Time Insights Monitor patient enrollment and drug supply across sites.
- ✔ Flexible & Scalable Supports single-site studies to global multi-site trials.
- ✔ Seamless Integration Works with GAJA EDC, eSource, eConsent, and eCOA for end-to-end trial management.
Features Of GAJA RTSM
- Randomization Management Supports simple, block, stratified, and adaptive randomization.
- Drug Inventory Tracking Real-time updates of stock levels at sites and central depots.
- Automated Supply Planning Predicts resupply needs based on enrollment and consumption.
- Patient Enrollment Tracking Monitor study progress and site activity.
- User Interactive Dashboards Visualize randomization and supply data with analytics.
- Audit Trails & Security Complete traceability of assignments and stock movements.
- Global Multi-Site Support Handles multiple countries, languages, and time zones.
Benefits of GAJA RTSM
Optimized Drug Supply
Tracks inventory in real time and predicts resupply needs to prevent shortages.
Accurate Randomization
Ensures error-free patient allocation and maintains study integrity.
Real-Time Insights
Provides instant visibility into enrollment, site activity, and supply status.
Regulatory Compliance
Fully adheres to 21 CFR Part 11 and ICH-GCP standards for secure, traceable operations.