White Paper

Traceable Chain Of Custody: Requirements For An eClinical Supply Chain Management Platform

Source: Slope
GettyImages-827582436-lab-samples-work-PPE

This paper is the third in a series exploring the necessary requirements for an eClinical Supply Chain Management (eCSCM) platform. For an eCSCM platform to optimize a clinical supply chain, there are four categories of requirements:

  1. Collaboration
  2. Real-Time Visibility
  3. Traceable Chain of Custody
  4. Compliance

This paper will detail the traceable chain of custody requirements for an eCSCM 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.

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