"Adoption of CDISC in the 制药/生物科技 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 韩国
Overseas regulatory agencies mandate or recommend the application of the International Clinical Data Standards (CDISC) when submitting basic clinical and non-临床试验 data. The 美国 (FDA) began mandating CDISC standards in 2017, and 日本 (PMDA), 中国 (NMPA), and others have followed. 欧洲 (EMA) also recommends CDISC standards. In contrast, CDISC utilization remains low in 韩国. Although the 食品医药品安全处 established the basis for CDISC-format submission of clinical and non-临床试验 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, 韩国'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/临床试验 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 临床试验.
While it varies by 临床试验 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 国内外 certifications, affiliated companies, and institutions.
First, key partnerships in the non-clinical sector: the company is collaborating with the 韩国毒性研究所 (KIT), the top non-clinical (toxicology) testing institution in 韩国, affiliated with the 韩国 Research Institute of Chemical Technology, and is continuously pursuing technical and business cooperation with the 韩国 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 bio制药公司 including Xymedi, Conext, and RudaCure.
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RudaCure carried out SEND processing of non-临床数据 for 美国 Phase 2 临床试验 in collaboration with Cluepi, and as the process approaches completion, preparations for FDA 临床试验 in 2023 are proceeding steadily.