Looping blockchain, distributed ledger tech into clinical research
Certara’s regulatory sciences division Synchrogenix has been building distributed applications to expand its reach in transparency and disclosure, regulatory reporting and data sharing, among other areas from drug development through market access.
In collaboration with Hedera Hashgraph, Synchrogenix has developed an industry supply chain management proof of concept (POC) focused on global drug shortages.
The Hedera platform will offer a distributed public ledger with diversified governance that enables developers to build decentralized applications, according to the companies.
Synchrogenix President Kelley Kendle said the technology eliminates third-party intermediaries, providing a secure infrastructure to achieve transparency and speeding transactions by digitizing information.
“Applying this technology will enable successful collaboration within and across research entities while providing the confidentiality and privacy provisions necessary to move the industry forward,” she told us.
The companies have already begun collaborating on use cases, which Kendle said can readily scale in the near term.
“The amount of data generated by the pharmaceutical industry and other stakeholders contributing information to the innovation paradigm is growing exponentially. We believe that investing in new technology, such as DLT [distributed ledger technology], will enable the industry to leverage that data to its fullest,” she added.
According to Kendle, new DLT, such as that developed by Hedera, can be used to address industry challenges, accelerating R&D and transparent decision-making. It also can enhance the security and ownership of confidential information to protect all stakeholder rights, she explained.
“It is a well-known fact that pharmaceutical research, regulatory compliance, and stakeholder communication are inefficient and costly,” Kendle said. This inefficiency is rooted in siloed operations that stifled collaboration, both within companies and across the broader industry.
“While there are research and development activities occurring in industry, academia, hospital networks and other types of institutions, the technology infrastructure is not optimized to capitalize on the myriad of seemingly insignificant activities that when combined can result in new, cutting-edge therapies,” explained Kendle.
Additionally, confidentiality and transparency requirements need to be met to spur such collaboration, while protecting patient privacy, she noted, adding, “These needs are especially pivotal in early-stage development and other translational aspects of successful R&D.”
Several companies across the industry are using blockchain tech to ensure data integrity. Some most recent examples include Alpha Genesis exploring the technology’s use in primate research activities and Scientist.com’s launch of DataSmart, which applies blockchain tech to protect data throughout the drug development process.
