• Advertise
  • Contact Us
  • About Us
  • Supplier Directory
  • SCB YouTube
  • Login
  • Subscribe
  • Logout
  • My Profile

  • CORONAVIRUS
  • LOGISTICS
    • Air Cargo
    • All Logistics
    • Express/Small Shipments
    • Facility Location Planning
    • Freight Forwarding/Customs Brokerage
    • Global Gateways
    • Global Logistics
    • Last Mile Delivery
    • Logistics Outsourcing
    • LTL/Truckload Services
    • Ocean Transportation
    • Rail & Intermodal
    • Reverse Logistics
    • Service Parts Management
    • Transportation & Distribution
  • TECHNOLOGY
    • All Technology
    • Artificial Intelligence
    • Cloud & On-Demand Systems
    • Data Management (Big Data/IoT/Blockchain)
    • ERP & Enterprise Systems
    • Forecasting & Demand Planning
    • Global Trade Management
    • Inventory Planning/ Optimization
    • Product Lifecycle Management
    • Sales & Operations Planning
    • SC Finance & Revenue Management
    • SC Planning & Optimization
    • Sourcing/Procurement/SRM
    • Supply Chain Visibility
    • Transportation Management
  • GENERAL SCM
    • Business Strategy Alignment
    • Education & Professional Development
    • Global Supply Chain Management
    • Global Trade & Economics
    • HR & Labor Management
    • Quality & Metrics
    • Regulation & Compliance
    • SC Security & Risk Mgmt
    • Supply Chains in Crisis
    • Sustainability & Corporate Social Responsibility
  • WAREHOUSING
    • All Warehouse Services
    • Conveyors & Sortation
    • Lift Trucks & AGVs
    • Order Fulfillment
    • Packaging
    • RFID, Barcode, Mobility & Voice
    • Robotics
    • Warehouse Management Systems
  • INDUSTRIES
    • Aerospace & Defense
    • Apparel
    • Automotive
    • Chemicals & Energy
    • Consumer Packaged Goods
    • E-Commerce/Omni-Channel
    • Food & Beverage
    • Healthcare
    • High-Tech/Electronics
    • Industrial Manufacturing
    • Pharmaceutical/Biotech
    • Retail
  • REGIONS
    • Asia Pacific
    • Canada
    • China
    • Europe
    • Latin America
    • Middle East/Africa
    • North America
  • THINK TANK
  • WEBINARS
    • On-Demand Webinars
    • Upcoming Webinars
  • PODCASTS
  • VIDEOS
  • WHITEPAPERS
Home » IRT’s Critical Role in the Clinical Supply Chain

IRT’s Critical Role in the Clinical Supply Chain

February 8, 2022
Andy Prinz, SCB Contributor and Jack Johnson, SCB Contributor
Interactive response technology (IRT), also referred to as randomization and trial supply management (RTSM), plays a central role in managing the drug supply during a randomized clinical trial. IRT informs the blinded clinical sites which pills to give to which patients, and keeps the supply chain in the loop to ensure the right product is in the right place at the right time within a potentially complex clinical trial.

IRT plays a central role in coordinating the investigational product (IP) while maintaining double blinding at a drug trial site. Its core functionality originated with assigning a protocol to each patient and supporting blinding of the clinics administering the treatment. For a simple trial with two protocols, where half the participants are receiving a placebo and the other half are receiving a consistent dose of the IP, the supply chain implications of the randomization are straightforward. The clinic has bottles of pills; half are labeled A and half are labeled B, and the clinic does not know what the difference is.

Many modern clinical trials, however, are much more complicated than the simple example demonstrated above. For instance:

  • If the drug is expensive, which it likely is due to the low production volumes of drugs that have not received FDA approval, the sponsor would not want to pay for excess inventory sitting at the clinics. 
  • If the drug is being trialed for patients with a relatively rare condition, this suggests a vast array of clinical sites are needed to support required patient volumes. Consequently, this multiplies the cost of excess inventory and increases the supply chain complexity. 
  • Many clinical trials are global in scale, with trials taking place across different continents to balance participant demographics.
  • Additional challenges come from drugs that have short shelf lives or stringent storage requirements (e.g. COVID-19 vaccines that need to be maintained at super cold temperatures). 
  • Lastly, many trials leverage a variety of different IP doses with potentially adaptive structures to speed time to market. The protocols for patients can change throughout the life of the trial as results are reported and certain protocols are deemed more effective than others. 

As such, the considerations above lead to a complex just-in-time (JIT) supply chain with the IRT managing the demand plan and feeding required information to the clinical supply team.

Modern clinical trials could not be as complicated without the advancement of IRTs to support them. Many IRTs can be configured in a matter of weeks to support highly complex trials. Integrations are available to connect the IRT’s demand plan to manufacturing and supply chain organizations — regardless of the firm running the trial — via the drug sponsor or a third-party provider. 

Outlook:
Any supply chain practitioner working within the life sciences sector should have a basic understanding of IRT. This is a critical piece of any clinical trial, especially as pressure grows to bring treatment to market more quickly.

Andy Prinz is managing consultant, and Jack Johnson is principal consultant, at PA Consulting.

RELATED CONTENT

RELATED VIDEOS

Pharmaceutical/Biotech
  • Related Articles

    Watch: The Critical Role of Human Capital in the Supply Chain

    Blockchain’s Critical Role in Supply-Chain Transparency

Andy Prinz, SCB Contributor

Why Mid-Sized Companies Should Consider Product Lifecycle Management Tech

More from this author
Jack Johnson, SCB Contributor

Why Mid-Sized Companies Should Consider Product Lifecycle Management Tech

More from this author

Wake up to live
“Supply Chains in Crisis”
updates and the latest Supply Chain News!

Subscribe to our Daily Newsletter

Timely, incisive articles delivered directly to your inbox.

Popular Stories

  • Medical drone

    Amazon May Be Proof That Delivery Drones Aren’t Practical

    Last Mile Delivery
  • digital work

    Supply Chain Managers Are Quitting in Unprecedented Numbers

    Coronavirus
  • North Jakarta, Indonesia

    Physical, Financial Visibility: A Dual Approach to Supply Chain Resilience

    Supply Chain Planning & Optimization
  • Heat Wave Triggers Blackouts

    Vast Swath of U.S. at Risk of Summer Blackouts, Regulator Warns

    Supply Chain Security & Risk Mgmt
  • Worker using tablet

    Podcast | Stitching Together the Physical and Digital Supply Chain

    Technology

Digital Edition

Scb may 2022 sm

2022 Supply Chain ESG Guide

VIEW THE LATEST ISSUE

Case Studies

  • 3PL Doubles Productivity With Robots to Fulfill Medical Supply Orders

  • E-Commerce Company Cuts Order Fulfillment Time by 40%

  • Fashion Retailer Halves Fulfillment Time With Omichannel Automation

  • Distributor Scales Business by Integrating Warehouse Automaton Software

  • Fast-Growing Fashion Brand Scales E-Commerce Fulfillment With Whiplash

Visit Our Sponsors

Yang Ming Alithya Barcoding
Blue Yonder BNSF Logistics Generix
GEP GIB USA GreyOrange
Here Honeywell Intelligrated Inmar
Keelvar Kinaxis Korber
Liberty SBF Locus Robotics Lucas Systems
Nvidia Old Dominion Parsyl
Redwood Logistics Saddle Creek Logistics Schneider Dedicated
Setlog Holding AG Ship4WD Shipwell
Tecsys TGW Systems Thomson Reuters
Tive Trailer Bridge Vecna Robotics
Whiplash    
  • More From SCB
    • Featured Content
    • Video Library
    • Think Tank Blog
    • SupplyChainBrain Podcast
    • Whitepapers
    • On-Demand Webinars
    • Upcoming Webinars
  • Digital Offerings
    • Digital Issue
    • Subscribe
    • Manage Your Subscription
    • Newsletters
  • Resources
    • Events Calendar
    • SCB's Great Supply Chain Partners
    • Supplier Directory
    • Case Study Showcase
    • Supply Chain Innovation Awards
    • 100 Great Partners Form
  • SCB Corporate
    • Advertise on SCB.COM
    • About Us
    • Privacy Policy
    • Contact Us
    • Data Sharing Opt-Out

All content copyright ©2022 Keller International Publishing Corp All rights reserved. No reproduction, transmission or display is permitted without the written permissions of Keller International Publishing Corp

Design, CMS, Hosting & Web Development :: ePublishing