A robust collaborative solution with real-time 360° visibility for the clinical supply chain.

In a world where we rely on burdensome paper trails, real-time decentralized technologies creats insight, security, and trust. KitChain is an iPhone and web application designed to create an immutable digital record for inventory and event tracking in the pharmaceutical clinical supply chain, built on technologies workshopped with FDA and key industry stakeholders.

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Highlights from SCOPE 2022

KitChain: Real-Time Tracking & Collaboration

A powerful framework driving real-time, high-fidelity clinical supply chain execution. KitChain’s fit-for-purpose iOS app, web-based executive dashboards, and verifiable credentials come together to deliver security, auditability, and donor/patient data privacy for the modern supply chain.

Study sites have access to rapid GS1-compliant barcode scanning, drug verification, and issue reporting, while sponsors and CMOs have a real-time single source of truth for cell & gene therapies. All built on real-time decentralized technologies workshopped with big pharma teams & FDA, with data available for review & analytics.

Product Tracking

Track product shipments throughout the supply chain in real time. Access real-time scanning functionality, track status of individual kits, batches & sites, and log for future auditability.

Data Integrity & Resilience

Verifiable credentials, workshopped with FDA, ensure a fully secure supply chain. Every interaction securely signed with robust, auditable identity and authentication.

Reduced Site Burden

No longer reliant on paperwork and manual transcription, sites have access to lightweight and easy tools to support inventory management workflows.

Collaborative Model

Work with partners within a data-aligned model robust to change management, developed by a cross-industry working group.

Real-Time Notifications

Event streams and trouble tickets drive seamless and timely review and resolution.

Asset Freezing

Trouble ticket mode freezes assets for management review. Rapidly and easily identify, coordinate, and resolve supply chain exceptions in real time.

Partner Registry

Single login capable of supporting an unlimited number of studies, built on open standards identity tools recognized by FDA and industry partnership.

Real-World Evidence

Granular real-time data augments and accelerates predictive models, reporting, and deep learning applications.

Control Tower

Monitor supply chain and system status with executive dashboards. Customized views and access privileges based on supply chain role and study configurations.

Whitepaper

Transforming Pharmaceutical Clinical Supply

Clinical studies are exploding in number, complexity, and scope, with increasingly specialized storage conditions and shorter windows of expiration. Clinical sites are struggling to meet these demands, which have sometimes forced them to turn away new studies. With personalized medicine on the horizon, these trends are likely to become even more challenging.

To address this challenge, the Clinical Supply Blockchain Working Group defined the core message format, data flow, and sharing functionality requirements for a secure and streamlined solution – KitChain.

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Video + Case Study

Scanning, Verification & Issue Reporting

  • Pilot conducted by IQVIA and LedgerDomain with the participation of a biopharma sponsor and two clinical sites

  • KitChain deployed and tested in parallel with existing inventory management, with standard kit codes added to the app and represented on a real-time dashboard for sponsor leadership

  • Kits verified against the system of record, ensuring that the kits onsite truly corresponded with the advance shipping notification

  • Inventory management speed increased 14x

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KitChain is sponsored by the Blockchain for Clinical Supply Chain – Industry Working Group (Pfizer, Biogen, AstraZeneca, Merck, GlaxoSmithKline, Thermo Fisher, IQVIA, UCLA, Deloitte, Marken, Bracket, and Almac). The solution is implemented in Hyperledger Fabric, an open source blockchain platform sponsored by the Linux Foundation. LedgerDomain provides additional proprietary software, and all members agree that LedgerDomain reserves all rights to its software and is not granting a license for further use or redistribution. Hyperledger and Hyperledger Fabric are property of Linux Foundation; LedgerDomain Selvedge and DocuSeal are property of LedgerDomain. The KitChain mobile app may not be downloaded or used by anyone under 13 years of age. All rights reserved. Learn more in our terms of use and privacy policy.