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[News]The Key to K-Bio’s Success: Independence, Securing Data and Technology Sovereignty

JNPMEDI PR
20 Feb 2025

| Korea’s Bio-Pharma Growth Depends on Protecting Core Tech and Clinical Data: Global Leadership at Stake

| High Reliance on Foreign Tech, Especially in Data Management, Creates a Gap with Global CROs

| Domestic CRO Solutions Emerging as Key to Strengthening Clinical Data Quality and Trust

| JNPMEDI Leverages AI to Maximize Accuracy, Empowering Korea’s Bio-Pharma with Data Sovereignty



As K-Bio continues to expand its presence in the global market, the protection of core technologies and clinical data has emerged as a critical issue determining the industry’s long-term sustainability. With the rapid growth of new drug development and digital healthcare, the value of clinical data is increasing. However the rising reliance on the global CROs and foreign cloud solutions raises concerns over the weakening data sovereignty of Korean bio companies


According to the ‘Korea Clinical Trials White Paper Vol. 3’ published by the Korea National Enterprise for Clinical Trials, while Korea's CRO industry is steadily growing, it remains highly dependent on foreign technologies for key areas such as data management and statistical analysis. This dependency has widened the gap between domestic and global CROs.


Another major issue is that as Korean pharmaceutical and biotech companies collaborate with foreign CROs for global clinical trials, clinical data is often stored on overseas servers or controlled by global corporations. This increases the risk of domestic companies being placed at a disadvantage in drug approval and R&D processes. Additionally, concerns over data security and personal information protection are becoming more pressing challenges.


To address these risks, Korean companies are developing domestic solutions and independent platforms to secure clinical data and achieve technological independence, thereby improving the research and development environment for the pharmaceutical and biotech industry.


■ JNPMEDI Establishes Independent Data Management System with Maven Clinical Cloud


JNPMEDI, a clinical trial consulting and platform company, has developed Maven Clinical Cloud, an all-in-one clinical trial data management platform. This solution prevents the outflow of clinical data overseas and helps Korean pharmaceutical and biotech companies establish an independent data management system. It provides customized services across all clinical trial stages, including clinical data collection and analysis, global regulatory compliance, decentralized clinical trial (DCT) support, and pharmacovigilance (PV).


Notably, Maven Clinical Cloud utilizes AI-driven data management and analysis technologies to maximize data accuracy and consistency while ensuring compliance with global regulatory standards, including the FDA. By replacing the data management functions previously reliant on global CROs and foreign cloud solutions with domestic technology, JNPMEDI empowers pharmaceutical and biotech companies to regain data sovereignty in global clinical trials.


As AI-based data standardization becomes a key factor in enhancing clinical trial efficiency and reliability, Maven Clinical Cloud is emerging as an integrated platform that supports real-time data management and global regulatory compliance. More importantly, by applying AI-based data management and analysis, the platform strengthens the reliability and quality of clinical data while fostering an environment where Korean pharmaceutical and biotech companies can establish independent data management systems.


■ GCCL Strengthens Clinical Data Reliability by Minimizing Sample Transfers


GCCL, a clinical trial sample analysis company, operates its proprietary One-Stop Lab Solution in the global market, integrating its Central Lab, Bioanalysis Lab, and BL3 facilities into a single platform. This system enables rapid and secure sample analysis within Korea, reducing reliance on foreign CROs and analysis institutions. By minimizing sample transfers, it not only significantly cuts costs and time for domestic pharmaceutical and biotech companies but also ensures sample stability, thereby providing more precise and reliable clinical data.


GCCL has also introduced cutting-edge analytical platforms and a global Laboratory Information Management System (LIMS) to meet high-quality standards in clinical research. With this infrastructure, GCCL enables domestic pharmaceutical and biotech companies to quickly and securely obtain clinical trial data within Korea while reinforcing data reliability throughout the entire R&D process.


■ JW Pharmaceutical Secures Research Data Protection and Technological Sovereignty Through AI Drug Development


JW Pharmaceutical, a leader in AI-driven drug development since 2010, is enhancing research data security and reducing reliance on foreign AI solutions through its proprietary AI drug development platform, JWave. Previously, the company operated separate platforms, Jewelry and Clover, but has now integrated them into JWave to create a unified system that enables independent data analysis from drug candidate discovery to development—all within Korea.


Furthermore, JW Pharmaceutical is transitioning to cloud-based systems to accelerate data processing and maximize drug development efficiency. This initiative strengthens Korea's AI drug development capabilities while preventing the outflow of research data overseas, ultimately advancing technological independence.