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[News]"We Will Achieve Regulatory Approval with Digital Clinical Solutions," says Seungmi Lee of JNPMEDI

JNPMEDI PR
17 May 2024

As artificial intelligence (AI) is applied across various industries, digital transformation (DX) is accelerating. However, technological advancements have been slow in the traditionally closed pharmaceutical clinical trial industry.


The one company aiming to innovate the clinical trial process by integrating digital technology is JNPMEDI, a clinical trial data management solution provider.



Founded in 2020, JNPMEDI has developed the 'Maven Clinical Cloud' solution, a clinical trial data management platform applicable to pharmaceuticals, biotechnology, medical devices, and digital therapeutics. The company is recognized for advancing the decentralized clinical trial market in Korea.


IT Chosun recently interviewed Seungmi Lee, a newly joined clinical trial expert at JNPMEDI, to discuss the limitations of the domestic clinical industry and the necessary changes to overcome these challenges.


Lee, who graduated from Yonsei University with degrees in nursing and psychology and completed a master's program at Seoul National University School of Public Health, has over 20 years of experience in the medical device industry. 


Her diverse roles included clinical research coordinator (CRC), project manager (PM), clinical trial monitor (CRA), head of clinical development at Synex, and strategic planning director at Olive Healthcare before joining JNPMEDI in March.


Lee stated, "I became interested in learning new methods as a nurse, which led me to work as a clinical research coordinator by chance. Over time, I wanted to experience the most innovative technologies in clinical practice." She emphasized the need for changes in the slow-paced clinical processes, from the initial stages to commercialization, to successfully bring new drugs to market.


Lee highlighted the importance of digitalizing the clinical process to minimize errors, particularly through database construction. She said, "I saw the potential for digitalization in clinical processes, especially in reducing errors through database construction."


To achieve this, JNPMEDI developed the 'Maven Clinical Cloud' platform. This SaaS-based one-stop clinical trial data management platform offers customizable services tailored to the scale and purpose of clinical trials. 


Lee explained, "Maven Clinical Cloud provides a range of functions, including decentralized clinical trial (DCT) service modules, data and document management, and pharmacovigilance (PV). It offers solutions for all stages of clinical trials, built on a microservices architecture that enhances operational convenience, maintenance, and cost-efficiency."



Lee particularly noted that the platform enables the systematic management of clinical trial data, enhancing data accuracy and reliability to streamline regulatory approval processes.


JNPMEDI is also planning new services based on AI and machine learning. Lee mentioned, "Integrating AI into clinical trials could support various tasks, including risk monitoring, a key global concern. This would greatly benefit biotech companies that struggle to hire specialized personnel."

 

JNPMEDI is also working on commercializing cancer early diagnosis technology. The company recently signed an agreement with SoluM Healthcare to develop and commercialize a sensor-based rapid cancer diagnosis solution, aiming to expand services to the U.S. and European markets.


This month, JNPMEDI launched the 'Total Digital Medical Business Boosting Solution,' expanding its business into consulting. This comprehensive service, based on the Maven Clinical Cloud solution, provides end-to-end consulting for the commercialization of pharmaceuticals and medical devices.


Lee expressed optimism about the new service, stating, "The new service is expected to significantly aid clients facing difficulties entering clinical trials and commercializing pharmaceuticals and medical devices. The advanced digital consulting will help minimize errors in clinical processes, enhancing operational efficiency and reducing costs."


Finally, Lee conveyed her determination to support biotech and medical device companies struggling with sophisticated clinical requirements, helping them successfully bring their innovative products to market.


"I've witnessed many cases where excellent technology couldn't be introduced due to stringent regulatory requirements. With my expertise and experience, I want to contribute to making JNPMEDI the optimal business partner for companies facing challenges in the commercialization of medical devices and pharmaceuticals," she concluded.