⎯⎯⎯ Captivate RTSM
Randomization and Trial Supply Management system
Captivate RTSM is a web-based Randomization and Trial Supply Management module designed to support a wide range of randomization strategies while maintaining operational simplicity, compliance, and audit readiness.
Built for sponsors and CROs running interventional studies, Captivate RTSM delivers robust randomization capabilities without the overhead and rigidity of traditional IRT systems.
Designed to integrate seamlessly with the Captivate clinical data platform, Captivate RTSM enables study teams to configure and manage randomization schemes, maintain blinding, and track investigational kits within a single, unified environment.
Easily configure simple randomization logic for straightforward study designs.
Support for randomization across protocol-defined factors to ensure balance.
Configurable block sizes for permuted block randomization strategies.
Support for dynamic randomization to maintain balance across treatment arms in real-time.
Enforcement of randomization rules at the point of assignment for compliance.
Logic managed centrally for consistent application across all sites and subjects.
Comprehensive support for both single- and double-blinded designs
Protects blind integrity through controlled access levels
Controlled and logged emergency unblinding workflows
Full traceability for all unblinding events during the study
Define kit identifiers centrally for efficient oversight across the study.
Assignment of kits based directly on randomization results.
Complete tracking of kit status throughout the entire study lifecycle.
Visibility into used, assigned, and available kits for sites and study teams.
Secure, web-based interaction with the RTSM module
Step-by-step workflows for randomization and kit assignment
Real-time confirmation for all randomization actions
Clear visibility into individual subject and kit history
Shared subject and study context with Captivate EDC.
Consistent tracking across randomization, kits, and clinical data.
Exports and reports that include critical randomization metadata.
Minimized reconciliation effort across clinical systems.
Compliance with 21 CFR Part 11 and Annex 11
Secure system access and data handling
Comprehensive audit trails for randomization and blinding
Documented traceability for inspections and monitoring
Avoids the rigidity of systems that require extensive customization.
Highly auditable alternative to manual or spreadsheet-based randomization.
Designed to support study needs without unnecessary operational burden.
For multiple randomization methods
Built-in support for unblinding
Aligned with randomization outcomes
Consistent context with Captivate EDC
Auditability without unnecessary complexity
Discover how Captivate can support your clinical research needs. Our team is here to answer questions and show you what’s possible.
