According to Christopher Petersen, chief technology officer and founder at Scientist.com, the online marketplace has been working on aspects of DataSmart since the company was founded in 2007, though the platform itself is the result of about a year’s worth of work.
“DataSmart brings together our existing processes together into a single comprehensive strategy as well as incorporate our data integrity initiative and third party supplier assessments,” Petersen told Outsourcing-Pharma.com.
Blockchain technology and data integrity
The DataSmart platform is based on proprietary blockchain technology developed by Scientist.com. The technology aims to enable pharmaceutical and biotechnology companies to demonstrate that supplier information and research data have remained untampered and unaltered.
“Cryptocurrencies use blockchain to prove that transactions are valid and occurred at a specific time, even in an environment where participants are not incentivized to help one another. That's the breakthough that makes cryptocurrencies possible,” explained Petersen.
“We've applied that same technology to prove the existence of data collected at a specific point in time, which has not been altered since, nor can be altered in the future,” he added.
Due to the fact that much of the data from late-stage preclinical and clinical phases is submitted electronically to regulators prior to drug approval, companies are consistently charged with proving that data has not been tampered with since it was originally obtained.
Within the biopharmaceutical industry, late-stage preclinical and clinical research is subject to 21CFR Part 11 guidance, in which the FDA outlines the use of electronic records and signatures.
“The cost and time spent adhering to 21CFR Part 11 has made it prohibitive to ensure data integrity at earlier stages of the drug discovery and development process,” said Kevin Lustig, CEO and founder, in a statement. “Our new DataSmart platform makes it possible to extend data integrity protections throughout the entire drug research process, from concept to clinic and beyond.”
An ongoing effort
Petersen says DataSmart is considered a long-term project for the company following its initial launch. Among the top priorities includes continuing to look for ways to raise the bar on data management and security.
“We think DataSmart is the most comprehensive data management strategy in the industry today, but our goal is drive best practices throughout the research services market,” said Petersen.