The new solution is intended to enhance visibility, transparency and tracking of trial samples. It also delivers real-time status updates to all associated chain of custody entities.
Chain of custody involves various stakeholders, data systems and extensive processes at clinical sites, requiring manual data entry, coordination between external and internal teams, and end-of-trial reconciliation.
Visibility into the chain ensures data integrity and traceability for regulatory agencies.
HSBlox strategy & operations chief Lynn Carroll said: “During clinical trials, multiple biological samples are collected at various clinical sites over an extended period of time.
“Flawless administration of the chain of custody is critical to sample management because correct handling impacts both the course and results of clinical trials.”
The new Digital Sample Manager is designed to provide sample tracking for an optimised and transparent process in cases of multiple participants.
It delivers immutable records to help in compliance and audits, along with receipt acknowledgement, reporting and reconciliation for mitigating the need for changes to existing workflows.
Carroll added: “HSBlox deploys its distributed ledger technology platform-and the use of smart contracts- automate tracking and permissioned disclosures among stakeholders including: trial sponsors, clinical sites, labs, clinical research organisations, auditors, shippers, local and third-party labs, as well as patients.”
The Digital Sample Manager solution is said to be suitable for life science and research organisations to maintain full clinical trial programme administration transparency.