THE DISTRIBUTED DATABASE
and one courier. We were brought together by a key insight: that new collaborative technologies are essential to the future resilience of the clinical supply chain. In 2019, we published our white paper, Transforming Pharmaceutical Clinical Supply With Blockchain, sharing the results of our work on a robust collaborative model for shipment and event tracking. Since then, we’ve seen major advances in
decentralised technologies for inventory track and trace, drug verification, and auditability. At the heart of these developments are two technologies: barcodes and blockchain. When you think of barcodes, you probably imagine that zebra-like set of lines you swipe at the self-checkout. While these 1D barcodes have been standard for decades, more recent barcode standards are much more powerful. In the US, the Drug Supply Chain Security Act (DSCSA) requires all prescription drug packages to have unique 2D barcodes with embedded product information, including the lot and serial number. Similar requirements are now in effect for the EU, Russia, Brazil, and other countries. Meanwhile, the global standards organisation GS1 has endorsed 2D barcodes for clinical studies in its Identification of Investigational Products in Clinical Trials Application Standard.
What is blockchain? With traditional databases, each organisation maintains its own systems of record, which often conflict with each other. A shipper might claim that a package was delivered, while a study site might have no record of it arriving. Getting to the bottom of the problem can be difficult and time-consuming. Blockchain is a type of distributed database that allows multiple organisations to share a “single version of the truth”. Every time a transaction occurs, it is notarised and written to the database. Cryptographic safeguards ensure each organisation has visibility only on their transactions, and not the transactions of others.
Because of these capabilities, blockchain is often associated with Bitcoin and similar cryptocurrencies. But as an immutable, time-stamped, real-time, auditable record of transactions, blockchain is also well-suited to supply chains where numerous organisations handle sensitive information.
“Blockchain is actively being used for government services, digital banking and pharmaceutical supply chain solutions. It is simply a new gold standard for data management.”
Track and trace By providing a shared source of truth, blockchain makes it possible for supply chain stakeholders to track and trace inventory in real time – from manufacturer to patient administration. CMOs can gauge overall inventory levels, while the study team can form a view as to whether the study drug is in the right place.
Auditability
Bringing a new drug to market is an enormous undertaking that requires scientific rigour and immaculate record-keeping, so that study results can be independently verified. Blockchain technology provides a tamper-proof recording trail while preserving privacy, making it suitable for logging patient consent, shipment statuses, and administration records.
Conclusion Blockchain platforms have come a long way over the past 10 years. Along with related decentralised technologies such as verifiable credentials, blockchain is actively being used for government services, digital banking, and pharmaceutical supply chain solutions – including saleable returns and chargebacks. In many cases, the users of these services never realise that blockchain technology is being used; it is simply a new gold standard for data management. The challenge ahead for clinical supply
stakeholders is to align on common standards and work flows, as collaborative applications demand tight alignment on data science. These efforts are ongoing in the Clinical Supply Blockchain Working Group and standards organisations such as GS1. Ultimately, blockchain will combine with artificial intelligence to make every transaction instantaneous, confidential, unforgeable, and trackable.
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