Clupea, a medical big data platform company, said on Tuesday that it will jointly establish the first non-clinical big data platform based on Clinical Data Interchange Standards Consortium (CDISC) standards with the Korea Institute of Toxicology (KIT).
Clupea and KIT to establish Korea's first Clinical Data Interchange Standards Consortium (CDISC) standard-based non-clinical big data platform
Clupea's Medilake platform technology, which is the only clinical and non-clinical CDISC data platform in Korea, will be used to build non-clinical big data at Clupea and the KIT.
The CDISC is an international clinical data standardization consortium in Korea. Using standardized clinical data from CDISC makes it easy to understand the data on research results globally, for improved data verification.
Until now, the data sent by institutions and companies around the world to regulatory agencies for review and approval after clinical trials are all handled in different formats. This is because the data was created in their own format without standardization of the data. However, if data is standardized in the form of CDISC, the time and economic loss for data preparation and review can be reduced by 70 percent, the company explained.
Advanced medical regulators such as the U.S. FDA, Japan's PMDA, and Europe's EMA have already adopted the CDISC as the standard. Countries that have adopted CDISC have established a non-clinical test database, but Korea is still lagging in this regard, Clupea said.
Accordingly, the KIT and Clupea have joined hands in this endeavor.
"This CDISC standard-based non-clinical big data construction will establish a data value chain from non-clinical trials to clinical trials through linkage and support with Clupea's CDISC clinical trial management platform," Clupea CEO Kim Ki-hwan said. “Furthermore, we will be able to leverage Medilake to support bio companies with business intelligence (BI) and artificial intelligence (AI) support for integrated non-clinical-clinical enterprise data management."