IWRS/RTSM

Octalsoft IWRS/RTSM (Interactive Web Response System / Randomization and Trial Supply Management) is a web-based clinical trial management solution designed for sponsors, CROs, and site teams. It covers subject randomization, investigational product (IP) supply management, blinding, and real-time trial oversight across Phase I–IV studies, including multi-center and global trials. The system is built to meet regulatory requirements including 21 CFR Part 11, GCP, and GDPR, and integrates with other eClinical tools such as EDC, CTMS, and ePRO.

The platform is intended to reduce manual effort, prevent dispensing errors, and support data-driven decision-making throughout the trial lifecycle. It serves sponsors seeking supply visibility and reporting, CROs managing multiple studies across sites, and site staff who need straightforward workflows for enrollment and IP allocation.

Randomization Capabilities

• Supports multiple randomization methods: simple, block, stratified, adaptive, and minimization.
• Configurable per study protocol and complexity level.
• Handles multi-arm, multi-stage, and response-adaptive trial designs.
• Ensures accurate and compliant patient treatment assignments.

IP Supply Management

• Automates resupply based on real-time consumption data and trial milestones.
• Predictive analytics calculate optimal buffer stock and overages.
• Accounts for site variability, trial complexity, and randomization schedules.
• Reduces manual logistics effort and improves supply chain efficiency.

Blinding and Allocation Concealment

• Enforces single, double, or triple blinding protocols.
• Uses role-based access controls and secure audit trails to protect treatment arm assignments.
• Maintains trial integrity through built-in concealment logic.

Digital Code Break System

• Replaces manual code envelopes with a secure digital unblinding process.
• Supports both emergency and non-emergency unblinding scenarios.
• Provides real-time authorization workflows for designated users.
• Sends built-in alerts and generates reports to maintain oversight and compliance.

Real-Time Monitoring and Reporting

• Sends customizable real-time alerts for events such as low stock levels or temperature excursions.
• Generates automated reports covering subject progress, IMP usage, and other trial metrics.
• Provides visual analytics to support data-driven decisions.
• Supports proactive IP replenishment and risk mitigation.

Usability and Scale

• Designed with an intuitive interface to reduce the learning curve for site coordinators and investigators.
• Clear navigation and workflows help prevent errors in enrollment and IP allocation tasks.
• Adaptable to trials of varying complexity and size, from Phase I through Phase IV.
• Supports consistency across multi-center and global clinical trials.

Role-Specific Benefits

• Sponsors: Trial setup management, supply logistics visibility, and real-time reporting tools.
• CROs: Multi-study management across global sites, protocol-specific configuration, and sponsor-site collaboration tools.
• Site Teams: Reduced manual work, error prevention in dispensing, and inventory management through a site-focused interface.

Add-ons and Integrations

• Integrates with Octalsoft EDC for real-time data capture and validation connected to randomization services.
• Integrates with Octalsoft ePRO for remote patient data entry within the IWRS environment.
• Part of a broader eClinical suite that includes CTMS and additional trial management modules.

Octalsoft IWRS/RTSM is offered alongside personalized onboarding, 24/7 support, and ongoing optimization services. The system is designed to comply with global regulatory standards and functions as part of an integrated platform covering the full clinical trial lifecycle.