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- What is RTSM?
- Where is it used in Clinical trials?
- How does Clinion implement it?
- What does it look like in practice?
- Related Terms
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What is RTSM?
RTSM (Randomization and Trial Supply Management) is a clinical trial system used to randomize subjects and manage investigational product (IP) or the drug supply throughout a study. It ensures that participants are assigned to treatment groups accurately and that the correct study medication is available at the right site and time.
In clinical trials, RTSM helps maintain blinding, controls inventory, tracks shipments, and supports compliance by automating randomization and supply workflows in a secure, auditable manner.
Where is it used in Clinical trials?
RTSM (Randomization and Trial Supply Management) is used throughout the subject enrollment and treatment phases of clinical trials. It is applied at investigative sites, sponsor teams, and CROs to manage both randomization and study drug supply.
Specifically, RTSM is used to:
- Assign participants to treatment groups as part of the randomization process.
- Track investigational product inventory at each site.
- Manage drug shipments, returns, and dispensing to ensure the right treatment is given at the right time.
- Maintain blinding and compliance with protocol requirements.
By centralizing these functions, RTSM ensures accurate treatment allocation and efficient management of clinical trial supplies.
How does Clinion implement it?
Clinion supports Randomization and Trial Supply Management (RTSM) by providing a centralized platform that handles both subject randomization and investigational product logistics. In this system, the randomization and trial supply management process ensures that eligible participants are assigned to treatment groups according to the study protocol, and that study drugs are allocated and tracked efficiently.
For trial supply management, Clinion monitors inventory at sites, manages shipments and returns, and ensures the right product is available at the right time. By integrating RTSM in clinical trials with eCRFs and other study systems, Clinion streamlines operations, reduces manual errors, and maintains compliance and audit readiness.
What does it look like in practice?
In practice, RTSM in clinical trials provides a real-time dashboard where study teams can manage both randomization and investigational product supply. When a subject is confirmed eligible, the system automatically handles the randomization process, assigning the participant to the appropriate treatment group and recording it securely.
For trial supply management, the system tracks inventory at each site, schedules shipments, manages returns, and ensures that the correct drug is available for each visit. This integration allows sites, sponsors, and monitors to see allocation status, inventory levels, and subject assignments at a glance, ensuring smooth operations and protocol compliance throughout the trial.
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RTSM