Clinion RTSM (Randomization and Trial Supply Management) is a specialized module or software solution that supports clinical trial operations by managing subject randomization and the supply of investigational products. These systems are critical in ensuring the integrity, efficiency, and compliance of clinical trials.
Key Components of Clinion RTSM
- Randomization Management:
- Implements randomization strategies such as block, stratified, or adaptive randomization.
- Ensures unbiased and reproducible assignment of participants to trial arms.
- Provides real-time randomization for sites to avoid delays.
- Trial Supply Management:
- Tracks inventory levels of investigational products across sites.
- Automates re-supply processes based on predefined thresholds.
- Prevents shortages or overstocking of trial materials.
- Blinding and Unblinding:
- Maintains the blinding of treatment assignments as per protocol requirements.
- Enables authorized personnel to unblind data when necessary for safety or analysis.
- Integrated Reporting:
- Real-time dashboards and analytics for randomization and supply metrics.
- Compliance tracking and detailed audit trails for regulatory purposes.
- Flexibility and Scalability:
- Customizable to suit various trial designs (e.g., single-arm, multi-arm, multi-site).
- Scalable for trials ranging from Phase I to Phase IV.
Benefits of Using Clinion RTSM
- Efficiency: Reduces manual effort in managing randomization and supplies.
- Data Integrity: Ensures compliance with regulatory standards like ICH GCP and 21 CFR Part 11.
- Real-Time Insights: Provides stakeholders with up-to-date information for decision-making.
- Cost-Effective: Optimizes resource allocation and minimizes waste in trial supplies.