| 'WELT-I', the 2nd Domestic Digital Therapeutic, Gains Approval Through Validation Clinical Trials... The First DCT Case for Digital Therapeutics in Korea Draws Attention
| JNPMEDI Applies 'Maven DCT Suite' to 'WELT-I' Validation Trials
| Complete Digital Transformation of Clinical Trial Processes Enhances Efficiency, Reduces Cost and Time, and Increases Data Analysis Accuracy, Proving the Effectiveness of DCT
In the midst of the birth of the 2nd domestic digital therapeutic 'WELT-I', it has gained attention as the first case in Korea to successfully conduct validation clinical trials for digital therapeutics through Decentralized Clinical Trial (DCT) methods.
Medical data platform company JNPMEDI (CEO Kwunho Jeong) applied its decentralized clinical trial solution, 'Maven DCT Suite', to the validation clinical trials of 'WELT-I', achieving successful completion and obtaining approval as a digital medical device, the first in Korea.
Developed by WELT, 'WELT-I' is an application-based software for treating insomnia, validated through efficacy and safety verification in clinical trials where JNPMEDI's 'Maven DCT Suite', known for its world-class performance, was employed. 'Maven DCT Suite' digitally transforms all stages of clinical trials, maximizing efficiency in △ time and cost, △ enhancing data integrity and reliability, and △ achieving high accuracy in data analysis.
JNPMEDI lowered the access barriers to clinical trials through its online subject recruitment solution, 'Maven eRecruitment', significantly increasing participant involvement and ensuring diversity among research subjects. This approach drastically reduced recruitment time and costs while minimizing participant visits to medical institutions by over 50% compared to traditional face-to-face methods, demonstrating the necessity and effectiveness of DCT.
Furthermore, by utilizing the DCT platform for screening processes (Maven Rscreening), obtaining eConsent for clinical trials, and collecting efficacy and safety data (Maven eCOA), JNPMEDI provided a patient-centered clinical trial environment, enhancing convenience. As a result, significant reductions in dropout rates were observed, further validating the success and necessity of DCT implementation.
Moreover, the systematic management of trial participant and clinical data collected from trial participants and clinicians through 'Maven CDMS', a clinical trial data management system, contributed to preserving sensitive clinical data without omission, ensuring accurate and reliable analysis, and providing technological support to facilitate the digital transformation of Korea's medical data market.
Kwunho Jeong, CEO of JNPMEDI, emphasized, "The successful completion of 'WELT-I's digital therapeutic validation clinical trials and the acquisition of a digital medical device approval are significant achievements that demonstrate the applicability of DCT in Korea's medical and healthcare industry." He added, "Based on our core business philosophy of prioritizing customer value, JNPMEDI will continue to lead the activation of the domestic DCT market by creating diverse successful cases and supporting relevant domestic institutions and industries struggling with clinical delays."
Meanwhile, the validation clinical trials of WELT-I, developed for the treatment of sleep disorders, evaluated the efficacy of sleep efficiency and improvements in insomnia between groups using WELT-I and those using a comparator device.
| 'WELT-I', the 2nd Domestic Digital Therapeutic, Gains Approval Through Validation Clinical Trials... The First DCT Case for Digital Therapeutics in Korea Draws Attention
| JNPMEDI Applies 'Maven DCT Suite' to 'WELT-I' Validation Trials
| Complete Digital Transformation of Clinical Trial Processes Enhances Efficiency, Reduces Cost and Time, and Increases Data Analysis Accuracy, Proving the Effectiveness of DCT
In the midst of the birth of the 2nd domestic digital therapeutic 'WELT-I', it has gained attention as the first case in Korea to successfully conduct validation clinical trials for digital therapeutics through Decentralized Clinical Trial (DCT) methods.
Medical data platform company JNPMEDI (CEO Kwunho Jeong) applied its decentralized clinical trial solution, 'Maven DCT Suite', to the validation clinical trials of 'WELT-I', achieving successful completion and obtaining approval as a digital medical device, the first in Korea.
Developed by WELT, 'WELT-I' is an application-based software for treating insomnia, validated through efficacy and safety verification in clinical trials where JNPMEDI's 'Maven DCT Suite', known for its world-class performance, was employed. 'Maven DCT Suite' digitally transforms all stages of clinical trials, maximizing efficiency in △ time and cost, △ enhancing data integrity and reliability, and △ achieving high accuracy in data analysis.
JNPMEDI lowered the access barriers to clinical trials through its online subject recruitment solution, 'Maven eRecruitment', significantly increasing participant involvement and ensuring diversity among research subjects. This approach drastically reduced recruitment time and costs while minimizing participant visits to medical institutions by over 50% compared to traditional face-to-face methods, demonstrating the necessity and effectiveness of DCT.
Furthermore, by utilizing the DCT platform for screening processes (Maven Rscreening), obtaining eConsent for clinical trials, and collecting efficacy and safety data (Maven eCOA), JNPMEDI provided a patient-centered clinical trial environment, enhancing convenience. As a result, significant reductions in dropout rates were observed, further validating the success and necessity of DCT implementation.
Moreover, the systematic management of trial participant and clinical data collected from trial participants and clinicians through 'Maven CDMS', a clinical trial data management system, contributed to preserving sensitive clinical data without omission, ensuring accurate and reliable analysis, and providing technological support to facilitate the digital transformation of Korea's medical data market.
Kwunho Jeong, CEO of JNPMEDI, emphasized, "The successful completion of 'WELT-I's digital therapeutic validation clinical trials and the acquisition of a digital medical device approval are significant achievements that demonstrate the applicability of DCT in Korea's medical and healthcare industry." He added, "Based on our core business philosophy of prioritizing customer value, JNPMEDI will continue to lead the activation of the domestic DCT market by creating diverse successful cases and supporting relevant domestic institutions and industries struggling with clinical delays."
Meanwhile, the validation clinical trials of WELT-I, developed for the treatment of sleep disorders, evaluated the efficacy of sleep efficiency and improvements in insomnia between groups using WELT-I and those using a comparator device.