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Blockchain Added to Clinical Trials Management

Blockchain network graphic

(TheDigitalArtist, Pixabay)

3 July 2019. A contract research organization, or CRO, specializing in clinical trials is adding blockchain capability for data management, with help from an engineering consulting firm. Clinlogix, a CRO near Philadelphia plans to use a blockchain system for its clinical trials, installed by ALTEN Calsoft Labs in Santa Clara, California.

Blockchain is a system for capturing data about transactions in a network, but with the data distributed among the various parties to the transactions. Data about a transaction are broken up into blocks, with each block connected in a chain. Each block is also time-stamped and encrypted with an algorithm giving it a unique identifier or fingerprint, also linked mathematically to the previous block in the chain. This linking of uniquely identified and encrypted blocks in the chain ensures the integrity of the data, as well as protects the data from hacking.

Clinlogix says it’s adding blockchain to its data management to provide better data protection for patients enrolled in its clinical trials. The partners in the project say Clinlogix will be the first organization to pilot test and implement blockchain in real-world clinical trials.

JeanMarie Markham, Clinlogix’s founder and CEO says in a ALTEN Calsoft blog post that the company is “one of the first, if not the first, CRO who is moving ahead with the rapid development and deployment of a blockchain based platform which will become an industry standard. Clinlogix has always embraced new technologies that improve patient outcomes, safety, and health along with helping our sponsors to get new treatments to market rapidly, efficiently, and cost effectively.”

ALTEN Calsoft Labs plans to install elements of the Strato blockchain network system offered by business software company BlockApps, specifically the middleware layer that integrates contracting and messaging functions with industry-specific networks and applications. BlockApps says Strato meets interoperability specifications of the Enterprise Ethereum Alliance, of which it’s a founding member, and is the first blockchain system to run on all three leading cloud computing platforms: Amazon Web Services, Microsoft Azure, and Google Cloud.

“Blockchain will introduce us all to a new age of transparency, privacy and traceability in all aspects of the life sciences as we know them,” says ALTEN Calsoft Labs life science partner Nick Spring, adding, “Blockchain has the power to fundamentally shift many core processes for drug research and development by increasing patient safety and privacy, improving quality of data, and significantly shortening the length of clinical trials.”

ALTEN Calsoft Labs says it has experience with clinical trial systems, helping an unnamed pharmaceutical company develop an application for patient recruitment, data collection, analysis, and tracking. Data in the trial came from online forms, smartphones, and tablet devices. The system, says the company, includes a database of 15,000 patients and supports clinical trial registration, payments to participants, and data mining with artificial intelligence.

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