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August 19, 2020

Mountains of Lab Kits

by
Rust Felix

Inventory surrounds us. It’s in your house, at your gas station, in your grocer’s freezer, and on the shelves of your Research Site’s supply closets and pharmacy. Inventory is something that demands attention and careful management. Your cat certainly wouldn’t be happy if you forgot to restock your pet food, and your subjects would be pretty upset if they had to reschedule their clinic visits because of a missing lab kit. Good inventory management keeps our lives running smoothly. In addition to people, clinical trials require lots of different study drugs, devices, lab kits, diagnostic equipment, specimen shippers, bulk supplies, freezers, centrifuges, laptops, and study materials. These things, which we refer to as clinical trial inventory, are absolutely crucial to the success of a study.

Clinical inventory management impacts everything and everyone.

Clinical inventory management is important because it touches practically every aspect of your Research Site’s clinical trial operations, including:

  • Subject enrollment and retention: It’s hard to enroll subjects and conduct follow-up visits if you don’t have all of the necessary materials on hand.
  • Staff efficiency: Your team is already too busy — clinical inventory management helps boost their efficiency. There’s more time to focus on your subjects when you spend less time triaging unexpected supply outages.
  • Sponsor perception: Whether you like it or not, your Sponsors, CROs, and monitors are always comparing your Research Site’s clinical performance to your peers. Stand out from the crowd by taking a proactive approach to managing your site’s clinical inventory.
  • Budget adherence: This may seem like an obvious concept, but many Research Sites forget to include clinical inventory management in their trial budgets. Stop leaving money on the table by including the time and cost to manage your inventory and the storage space to store it in your trial budgets.
  • Reducing waste: Here’s a blog post I wrote for the ACRP that describes how excess inventory creates tremendous waste, takes up precious space in supply closets, and hurts site efficiency.
  • cGCP Compliance: Principle 2.13 of the Good Clinical Practice guidelines remind us that “Systems with procedures that assure the quality of every aspect of the trial should be implemented.” Gentle reminder that spreadsheets, due to their traceability issues, are not a cGCP compliant solution for clinical inventory management.

While it sounds daunting, clinical inventory management isn’t too difficult. The key is to know what you have, what you need, and where it’s located.

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Traceable Chain of Custody Requirements for an eClinical Supply Chain Management Platform
Biological samples from subjects are the most valuable assets that travel across the clinical trial’s supply chain. Any gap in the knowledge in the biological sample's lifecycle can make the subject non-evaluable and jeopardize overall data integrity. If this happens too often, the overall clinical trial can be at risk. When shipping biological samples, clinical research sponsors must have the data they need to conduct biological sample reconciliation—meaning they have documentation to track a biological sample stored in a biorepository back to the lab that analyzed it, the courier that transported it, the research site that collected it, the lab kit that was used and its lot and serial number, and the lab kit’s distributor and manufacturer. This data allows the sponsor to prove that a biological sample is valid and has not been tainted anywhere along the way. As a result, an online platform must maintain an immutable record of all of the steps a biological sample takes throughout its journey from collection through storage, along with the steps taken by each collaborator, including sponsors, contract research organizations (CROs), research sites, distributors, labs, and couriers. As a result, an eCSCM platform must be able to prove a traceable chain of custody for biological samples, lab kits, investigational product (IP), devices, and ancillary and other clinical supplies, whether in use, transit, or storage.