Dubbed DataSmart, the platform will allow biotechnology and pharmaceutical companies to demonstrate the veracity of electronically submitted research data to regulators – specifically that which companies obtain during the preclinical and clinical stages of drug development.
“In biopharma research we need blockchain technology to verify and validate the supply chain and to ensure the integrity of research data,” Chris Petersen, Scientist.com’s CTO and founder said in a statement, adding:
“Our new DataSmart platform enables pharmaceutical and biotech companies to demonstrate that critical supplier information and important research data has not been tampered with and remains unaltered.”
The company said the service will specifically help biopharmaceutical firms comply with 21CFR Part 11, a regulation that outlines the standards electronic records must meet in order for the U.S. Food and Drug Administration to consider them reliable and equivalent to paper records.
“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,” Scientist.com CEO and founder Kevin Lustig said in the statement.
Big pharma firms Pfizer, Amgen and Sanofi also started exploring blockchain applications to the industry in January. The companies are specifically pursuing use cases related to data management and movement and patient communication automation among others.