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eBalance (IWRS)

Randomization and drug supply management for clinical trials with block, dynamic minimization, and stratified methods, plus intelligent inventory tracking and audit trails.

Solution by Taimei Technology
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Overview

eBalance (IWRS/RTSM) is a Randomization and Trial Supply Management System developed by Taimei Technology, designed to support the full lifecycle of investigational product (IP) management and subject randomization in clinical trials. The platform is built for clinical data management teams seeking diverse randomization capabilities combined with intelligent drug supply oversight, all within a system that integrates seamlessly with other trial software for efficient data exchange.

eBalance is purpose-built to reduce drug waste, streamline dispensing workflows, and provide complete traceability across all trial supply activities — making it suitable for complex, multi-site clinical studies of varying scale and design.

Randomization Capabilities

  • Supports multiple randomization methods including block randomization, dynamic minimization, and stratified randomization, among others
  • Accommodates multi-cohort and multi-stage trial processes
  • Subject replacement is supported to handle protocol deviations or withdrawals

Investigational Product (IP) Management

  • Comprehensive dispensing plans that cover trial supplies, scheduled visits, and treatment protocols
  • Full end-to-end tracking of drug transport, recovery, temperature excursions, destruction, and dispensing events
  • Dynamic monitoring of site-level inventory with automatic resupply triggers to prevent stockouts
  • Multi-dimensional reporting covering subject data, enrollment progress, trial supply inventory, and individual item details for complete project oversight

Alerts and Notifications

  • Configurable SMS and email alerts for key events including randomization, drug dispensing, unblinding, supply transfers, and abnormal drug status changes
  • Project team members receive email notifications with downloadable PDF attachments suitable for archiving and audit purposes

Audit Trail and Traceability

  • Subject Audit Trails that track each subject's journey from enrollment through to study completion
  • Drug Audit Trails that monitor all drug movements from initial assignment through to final disposal
  • Configuration Audit Trails to record system and protocol configuration changes

eBalance integrates within the broader Taimei Technology ecosystem, which includes eCollect (EDC), eCooperate (CTMS), eArchives (eTMF), and eCOA, enabling seamless data exchange across clinical trial operations. The platform is designed to support regulatory compliance requirements through its comprehensive audit trail functionality and full traceability features.

Meta

Domain
Clinical Trial Management
Subdomain
Randomization & Trial Supply Management
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11GxP