"Adoption of CDISC in the pharmaceutique/biotechnologie industrie 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 clinique 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-essai clinique 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 Ministère de Food and Drug Safety established the basis for CDISC-format submission of clinical and non-essai clinique basic data in April of l'année dernière, it has not yet been confirmed whether any company has actually submitted CDISC-based data and had it reviewed.
Cluepi is l'entreprise that developed MediLake, Korea's first CDISC data-based integrated non clinique/clinical management plateforme.
▲The MediLake plateforme satisfies the complex requirements of GAMP 5 guidelines and FDA 21 CFR Part 11 in non clinique/essais cliniques 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 essais cliniques.
While it varies by essai clinique 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 tels que national and international certifications, affiliated companies, and institutions.
First, key partenariats in the non clinique sector: l'entreprise is collaborating with the Korea Institute of Toxicology (KIT), the top non clinique (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.
L'entreprise is cooperating on SEND with non clinique CROs BioToxTech and ChemOn, and is providing CDISC SEND data services for approximately 40 new drug substances across 10 bioentreprises pharmaceutiques notamment Xymedi, Conext, and RudaCure.
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RudaCure carried out SEND processing of non-données cliniques for U.S. essais cliniques de Phase 2 in collaboration with Cluepi, and as the process approaches completion, preparations for FDA essais cliniques in 2023 are proceeding steadily.