"Adoption of CDISC in the pharmaceutical/biotech industry is no longer optional — it's mandatory"
DP Interview] Kim Ki-hwan, CEO of Cluepi
Overseas regulatory agencies mandate CDISC standards when submitting clinical and non-clinical basic data
Adoption of CDISC standards accelerates review and regulatory approval — Cluepi leads CDISC providers in Korea
Overseas regulatory agencies mandate or recommend the application of the International Clinical Data Standards (CDISC) when submitting basic clinical and non-clinical trial data. The U.S. (FDA) began mandating CDISC standards in 2017, and Japan (PMDA), China (NMPA), and others have followed. Europe (EMA) also recommends CDISC standards. In contrast, CDISC utilization remains low in Korea. Although the Ministry of Food and Drug Safety established the basis for CDISC-format submission of clinical and non-clinical trial basic data in April of last year, it has not yet been confirmed whether any company has actually submitted CDISC-based data and had it reviewed.
Cluepi is the company that developed MediLake, Korea's first CDISC data-based integrated non-clinical/clinical management platform.
▲The MediLake platform satisfies the complex requirements of GAMP 5 guidelines and FDA 21 CFR Part 11 in non-clinical/clinical trials without requiring extensive programming and work for CDISC data collection/management. This enables the rapid and efficient creation of eCRFs, the most critical element for data collection in clinical trials.
While it varies by clinical trial stage, the 6–12 weeks previously required for eCRF creation and validation is reduced to 1–2 weeks with MediLake — a reduction of approximately 80% in time required.
MediLake's technical capabilities can also be evaluated through objective indicators such as domestic and international certifications, affiliated companies, and institutions.
First, key partnerships in the non-clinical sector: the company is collaborating with the Korea Institute of Toxicology (KIT), the top non-clinical (toxicology) testing institution in Korea, affiliated with the Korea Research Institute of Chemical Technology, and is continuously pursuing technical and business cooperation with the Korea Testing & Research Institute.
The company is cooperating on SEND with non-clinical CROs BioToxTech and ChemOn, and is providing CDISC SEND data services for approximately 40 new drug substances across 10 biopharmaceutical companies including Xymedi, Conext, and RudaCure.
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RudaCure carried out SEND processing of non-clinical data for U.S. Phase 2 clinical trials in collaboration with Cluepi, and as the process approaches completion, preparations for FDA clinical trials in 2023 are proceeding steadily.