Q2 Solutions conducted a sample tracking proof-of-concept (POC) using distributed ledger technology (DLT, aka blockchain) in partnership with HSBlox. The goal of the POC was to explore real-time tracking of human biological samples in clinical trials. The POC simulated collection, transportation, test result generation, and storage of the sample.
During clinical trials, human biological samples are collected at clinical investigator sites over an extended period. Flawless administration of the chain of custody is critical to sample management because correct handling impacts both the course and results of clinical trials. Defective sample management can involve missing or contaminated samples, incomplete data, delays in reporting results, and substandard logistics. This leads to higher costs, lack of transparency, and other problems that can be avoided with the use of better technology like DLT.
"The FDA and other regulatory bodies are tightening their scrutiny of traceability and chain of custody for clinical research and trials," said to Brian O'Dwyer, CEO of Q2 Solutions. "There is no industry standard regarding the exchange of chain of custody information. DLT is a great technology for ensuring trust in the data." This POC demonstrated that a sample tracking solution using DLT can dramatically streamline the collection and sharing of information. Multiple clinical trial stakeholders---each with their own systems and data repositories---represent an intelligent distributed network for gathering and disseminating clinical and operational data relevant to the trial and its outcome.
HSBlox's DLT smart contract-enabled solutions bring automation, transparency, and tracking of permissioned data disclosure to the clinical research ecosystem. "We are proud to provide a best-in-class approach to biological sample tracking," said Rahul Sharma, CEO of HSBlox.
HSBlox is a partner of R3, the enterprise blockchain software firm. For the POC, HSBlox's patent-pending Digital Sample Manager (DSM™) solution utilized R3's Corda blockchain platform and was deployed in Microsoft Azure.
"This project, which requires highly accurate tracking through a complex chain which might be made up of many different parties, is ideally suited to blockchain. The decentralized nature of blockchain ensures transparency and trust, while Corda's enhanced privacy and security technology can ensure that sensitive data is handled with the appropriate care," said David E. Rutter, CEO of R3. "This innovative application introduces much needed additional controls and clarity to vital scientific research. We look forward to supporting the continued development of this application through the Corda ecosystem."