How will Blockchain technology, which has already had a major impact on financial services, revolutionize data security and Quality Assurance?
It’s all over the media and people everywhere are talking about it. It’s advertised as the next big thing, driving new technologies and disrupting existing economies. It is attributable, legible, contemporaneous, original, and accurate (ALCOA)—sound familiar? So what exactly IS Blockchain, and more importantly, why should you care?
Have you heard of Bitcoin? Whether you realize it or not, you’re also familiar with Blockchain technology. In short, it is a decentralized database system, i.e. with no central authority, that uses a timestamp audit trail to ensure an accurate record of transactions. The database is structured, such that records are stored as “blocks”, and each block is “chained” chronologically to one another with a cryptographic signature. This makes monitoring where the data/product/money is in its lifecycle very easy.
Touted as tamper-proof, Blockchain maintains data integrity by distributing copies of the linked records to multiple servers across a large network. This makes illicit changes impractical since altering one record in a single block would require all copies of that record across the network to be changed simultaneously to avoid detection. Importantly, blockchains can also be programmed to have “SmartContracts”. These are action switches embedded within the chain that read transactions, e.g. date stamps and select outcomes based on predefined criteria. Together these measures are incredibly powerful, allowing organizations to show unequivocally that their data is accurate and complete.
Already proving to be an invaluable new tool in the supply chain management and financial business sectors, Blockchain has now made its way to the pharmaceutical industry. In recent years, the sector has been faced with many challenges including an increase in product development costs, longer regulatory approval times, patent protection, security of patient data, and management of large digital data sets, the latter issue being particularly significant since there has been a sharp increase across the industry in regulatory infractions relating to data integrity.
Due to its inherent ALCOA properties, regulators are now considering the application of Blockchain to their reviewing process. In fact, the FDA is currently partnered with IBM Watson Health in a two-year pilot project to test the capabilities of Blockchain in making the drug monitoring and submission process faster, more cost-efficient and, importantly, transparent. While project findings aren’t due until January 2019, the pharmaceutical industry isn’t waiting. Already an initiative called MediLedger has been started to develop Blockchain tools to monitor supply chain management.
No doubt Blockchain is going to make an impact in the drug development industry. The question is—how will it impact you?