Life Science online research marketplace Scientist.com has announced that the company has created a solution to ensure the security of clinical information. The platform, DataSmartTM, will ensure that data obtained by biopharmaceutical companies from clinical trials has not been alteredwhen it is sent to regulators. The drug development program usually consists of four steps: discovering and developing the product, pre-clinical research, clinical research and drug reviews. Since data needs to be delivered to different locations, using an electronic service is easier, cheaper and faster.
However, such situations may lead to forged documents and unreliable information. Hence, DataSmartTM will be used to send research information to regulators before the drug is approved. Scientist.com CTO and Founder, Chris Petersen, said, “Blockchain’s ability to ensure the integrity of information is the basis of its use in cryptocurrencies. In biopharma research we need blockchain technology to verify and validate the supply chain and to ensure the integrity of research data. Our new DataSmartTM 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 blockchain platform will also make sure that companies follow the Code of Federal Regulations (21CFR Part 11) established by the United States Food and Drug Administration (FDA). According to Part 11, electronic records and signatures are considered as authentic as paper records and signatures by the FDA. Kevin Lustig, CEO and Founder of Scientist.com, shed some light on the topic, “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. Our new DataSmartTM platform makes it possible to extend data integrity protections throughout the entire drug research process, from concept to clinic and beyond.”
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