"Adoption of CDISC in the pharmaceutical/biotech industria is no longer optional — it's mandatory"
DP Interview] Kim Ki-hwan, CEO of Cluepi
Overseas regulatorio agencies mandate CDISC standards when submitting clinical and non-clinical basic data
Adoption of CDISC standards accelerates review and regulatorio aprobación — Cluepi leads CDISC providers in Korea
Overseas regulatorio agencies mandate or recommend the application of the International Clinical Data Standards (CDISC) when submitting basic clinical and non-ensayo clínico 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 establecido the basis for CDISC-format submission of clinical and non-ensayo clínico basic data in April of el año pasado, it has not yet been confirmó whether any company has actually submitted CDISC-based data and had it reviewed.
Cluepi is la empresa that developed MediLake, Korea's first CDISC data-based integrated non-clinical/clinical management plataforma.
▲The MediLake plataforma satisfies the complex requirements of GAMP 5 guidelines and FDA 21 CFR Part 11 in non-clinical/ensayo clínicos without requiring extensive programaming and work for CDISC data collection/management. This enables the rapid and efficient creation of eCRFs, the most critical element for data collection in ensayo clínicos.
While it varies by ensayo clínico stage, the 6–12 weeks previously required for eCRF creation and validation is reduced to 1–2 weeks with MediLake — a reduction of aproximadamente 80% in time required.
MediLake's technical capabilities can also be evaluated through objective indicators such as nacional e internacional certificacións, affiliated empresas, and instituciones.
First, key asociacións in the non-clinical sector: la empresa 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 cooperación with the Korea Testing & Research Institute.
La empresa is cooperating on SEND with non-clinical CROs BioToxTech and ChemOn, and is providing CDISC SEND data services for aproximadamente 40 new drug substances across 10 bioempresas farmacéuticas including Xymedi, Conext, and RudaCure.
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RudaCure carried out SEND processing of non-clinical data for U.S. Phase 2 ensayo clínicos in colaboración with Cluepi, and as the process approaches completion, preparations for FDA ensayo clínicos in 2023 are proceeding steadily.