Cluepie, Mid-term Report on the ‘Global Medical Data Support Project for Approval and Licensing’ Hosted by the Ministry of SMEs and Startups

[Asia Economy Reporter Yoo Hyun-seok] Medical big data platform company Cluepi announced on the 6th that it attended the mid-term inspection report and seminar of the ‘BIG3 (3 Major New Industries) Company Global Regulatory Submission SEND Support Service Project’ hosted by the Ministry of SMEs and Startups (MSS).

‘SEND (Standardization for Exchange of Nonclinical Data)’ refers to standardized international standard test data for nonclinical trials (such as animal testing) of new drugs based on the electronic Common Technical Document (e-CTD). In 2018, the U.S. FDA codified the submission of SEND documents for nonclinical and clinical trial data required for new drug approvals, and recently, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) also codified this requirement.

The ‘SEND Support Service for BIG3 Companies’ is a project hosted by the MSS. In July, ‘Safety Evaluation Research Institute’ selected Cluepi as the service provider through a bidding process. Through this project, Cluepi developed the SEND platform ‘Medilake-SEND’. By establishing an integrated platform for nonclinical and clinical trials, Cluepi plans to produce SEND data for the 22 BIG3 demand companies participating this time.

The recently held mid-term inspection report and seminar were attended by Cluepi, BIG3 participating companies benefiting from or interested in the SEND support service, and related experts. They presented and discussed ▲ progress of the SEND support service project ▲ difficulties encountered during the project ▲ actual cases of SEND conversion ▲ domestic and international SEND response status and U.S. FDA registration.

Kim Ki-hwan, CEO of Cluepi, said, “Based on the achievements shown in the medical data field so far, Cluepi was selected as the SEND service provider in July, and we reported on the progress of the project this time,” adding, “Through this project, we will help domestic BIG3 companies practically in obtaining global certification.”

He continued, “The ‘Medilake-SEND’ developed by Cluepi is a cloud-based big data framework platform capable of collecting and analyzing clinical and medical data,” and said, “Based on this platform, we will be able to provide BIG3 demand companies with low-cost, high-efficiency SEND data services and regulatory submission data conversion services in the form of international standards.”

This content was produced with the assistance of AI translation services.