Medical data platform company JNPMEDI applied its decentralized clinical trial solution 'Maven DCT Suite' to digital therapeutics company WELT's confirmatory clinical trial of 'WELT-I', an insomnia treatment. For the first time in Korea, it was announced that they had completed a digital therapeutics confirmatory clinical trial through DCT and succeeded in obtaining digital medical device item approval.
‘WELT-I’, developed by WELT, is an application-type sleep disorder treatment software, and JNPMEDI’s ‘Maven DCT Suite’ was applied in a confirmatory clinical trial to verify efficacy and safety in order to obtain product approval. 'Maven DCT Suite', developed by JNPMEDI, is a clinical trial platform with world-class high performance. By digitally converting all processes of clinical trials, it maximizes efficiency of time and cost, enhances data integrity and reliability, and has outstanding strengths in data analysis accuracy, among other benefits.
Through 'Maven eRecruitment', a solution for recruiting subjects online, JNPMEDI has lowered the barriers to access to clinical trials and increased the participation rate of research subjects, saving time and money.
In addition, the DCT platform is used to conduct clinical trial processes such as screening for suitability of research subjects (Maven Rscreening), obtaining consent for clinical trials (Maven eConsent), and collecting clinical trial efficacy and safety data (Maven eCOA). Convenience is improved by providing a patient-centered clinical trial environment. As a result, the number of visits to medical institutions by subjects decreased by more than 50% compared to the case of the existing face-to-face method, and the dropout rate also significantly decreased, proving the necessity and effectiveness of adopting DCT.
The official of JNPMEDI was quoted as saying “We will take the lead in revitalizing the domestic DCT market by creating various success stories so that DCT can be actively introduced to related institutions and industries in Korea that are suffering from clinical delays.”