Medidata provides clinical trial solutions for Genexine’s global phase 2/3 trials for COVID-19 vaccine
- Medidata provides Genexine with a clinical cloud platform to improve clinical research efficiency and support large-scale multinational clinical trial capabilities
- Following the adoption of eConsent and EDC for phase 1/2a, Genexine aims for digital transformation during phase 2/3
Seoul, Korea – July 14, 2021 - Medidata, a Dassault Systèmes Company, today announced that Genexine agreed to use its integrated data platforms, Rave EDC and Rave RTSM, for conducting the global phase 2/3 trials of its Covid-19 DNA vaccine candidate, GX-19N. Genexine plans to conduct a large-scale multinational phase 2/3 trials of GX-19N in Indonesia with 5,000 participants and increase the number to 30,000.
Medidata is to support the collection and management of clinical data with Rave EDC and help Genexine randomize its trials and manage the supply of drugs with Rave RTSM.
Like the GX-19N phase 1/2a study last year, Genexine aims to digitally transform its clinical trial process by adopting Medidata's solutions and enhancing its capabilities in data management. As it was difficult for clinical trial participants and researchers to meet face-to-face, Medidata supported Genexine to plan out decentralized trials during phase 1/2a trials and provided eConsent to phase 1b studies for their COVID-19 treatment candidate, GX-17.
Rave EDC system allows clinical research teams to capture, cleanse, and manage study data. It also can be integrated with other Medidata solutions. When the system is combined with Rave RTSM, users can prevent duplicated data and efficiently manage and analyze data, increasing the overall clinical trial efficiency and reducing costs and risks.
The Head of Genexine's clinical development team said that "Genexine is hoping to increase the efficiency of the vaccine development process and shorten the time required for completing clinical trials with Medidata's solution."
Journey Hong, General Manager of Medidata Korea, said, "Medidata has built a virtual clinical environment for Genexine by providing eConsent for its phase 1b clinical trial of Covid-19 treatment drug. Genexine has a mission to save patients' lives and improve their quality of life by developing innovative therapeutics, which meets the same goal. Medidata will continue to support Genexine so that the company can efficiently collect and manage data for its global GX-19N clinical trials."
Genexine, Inc., listed on KOSDAQ (095700) since 2009, is a leading biotherapeutics company focused on immuno-oncology and orphan disease. Genexine has a robust pipeline of products in the clinical stage, e.g. Hyleukin-7TM, HyTropin (GX-H9), Papitrol (GX-188E), etc. based on long-acting Fc fusion technology and therapeutic DNA vaccine technology. Genexine has completed multinational phase II trials and is preparing to apply IND of US Phase III trial for HyTropin (long-acting human growth hormone, hGH-hyFc). Papitrol, a therapeutic DNA vaccine for HPV-associated diseases, is under Phase II in Europe and Korea for Cervical Intraepithelial Neoplasia (CIN) II/III.
Medidata is leading the digital transformation of life sciences, creating hope for millions of patients. Medidata helps generate the evidence and insights to help pharmaceutical, biotech, medical device and diagnostics companies, and academic researchers accelerate value, minimize risk, and optimize outcomes. More than one million registered users across 1,700+ customers and partners access the world's most-used platform for clinical development, commercial, and real-world data. Medidata, a Dassault Systèmes company (Euronext Paris: FR0014003TT8, DSY.PA), is headquartered in New York City and has offices around the world to meet the needs of its customers. Discover more at www.medidata.com and follow us @Medidata.
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