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eCaseLink RTSM

Randomization, subject enrollment, and drug supply management for clinical trials with integrated EDC capabilities.

Solution by DSG
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Overview

eCaseLink RTSM is a Randomization and Trial Supply Management system developed by DSG, designed for use in both decentralized and traditional clinical trials. It functions as a fully integrated component of the eCaseLink unified platform, supporting randomization, subject enrollment, and drug supply management across studies of varying size and complexity.

The system is positioned as a cost-effective alternative to IVR-based approaches, with DSG reporting average savings of over $100,000 USD per study. It supports stand-alone deployment or full integration with eCaseLink EDC software, and is suitable for sponsors and research teams seeking end-to-end supply chain visibility alongside electronic data capture.

Core Features

  • Remote randomization and automated patient randomization workflows
  • Real-time access to randomization and supply data and reports
  • Customized reporting and web-based reporting tools
  • Data integration functionality across the trial platform
  • Rapid and flexible implementation adaptable to any study size
  • End-to-end supply chain management
  • Management of randomization and subject enrollment
  • Readiness for risk-based monitoring (RBM)
  • Reduction of total study cost

Drug and Device Delivery Solutions

  • Direct-to-Patient delivery
  • Depot-to-Patient delivery
  • Site-to-Patient delivery
  • Hybrid solutions incorporating one or more delivery methods

Inventory Management

  • Centralized management of clinical trial drug supply across the supply chain
  • Automated supply shipments from depots to sites or patients
  • Management of resupply from shipment facilities
  • Automated messaging triggered by preset low supply thresholds to support timely and accurate delivery

Integration and Efficiency

  • Integrates with eCaseLink EDC software as a stand-alone module or as part of the full unified platform
  • Includes electronic patient diaries fully integrated with eCaseLink
  • Reduces or eliminates the need for IVR systems in favor of a web-based approach
  • Lowers error rates, particularly in the context of mid-study protocol changes
  • Supports drug accountability tracking throughout the supply chain
  • 24/7/365 technical support available on-call or in-house

eCaseLink RTSM is offered by DSG as part of its broader eCaseLink platform, which also includes EDC capabilities. The system is designed to handle protocol deviations and supports administration across various clinical trial settings, with flexible implementation options intended to accommodate studies of different scales and designs.

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)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11HIPAAGDPRISO 27001