JNP Medi "Welt Insomnia Digital Therapeutic Device Applies DCT in Clinical Trials"

Medical data platform company J&P Medi announced on the 21st that the decentralized clinical trial solution 'Maven DCT Suite' was applied to the confirmatory clinical trial of the insomnia treatment 'WELT-I' by digital healthcare company Welt.

[Image provided by J&P Medi]

With WELT-I receiving approval as the second domestic digital therapeutic device from the Ministry of Food and Drug Safety on the 19th, it has become the first in Korea to complete a confirmatory clinical trial of a digital therapeutic through DCT and obtain approval for a digital medical device product. WELT-I is a sleep disorder treatment software in the form of an application.

Welt applied J&P Medi's 'Maven DCT Suite' in the confirmatory clinical trial verifying efficacy and safety to obtain product approval. Maven DCT Suite, a clinical trial platform developed by J&P Medi, digitizes all processes of clinical trials. Through this, it features ▲maximization of time and cost efficiency ▲strengthening of data integrity and reliability ▲highly accurate data analysis precision, J&P Medi explained.

J&P Medi lowered the entry barriers to clinical trial access and increased participation rates of research subjects through a solution that recruits subjects online. Additionally, by conducting the clinical trial process including screening to select the suitability of research subjects using the DCT platform, convenience was enhanced.

Jung Kwon-ho, CEO of J&P Medi, said, "The completion of the confirmatory clinical trial of the digital therapeutic WELT-I and the acquisition of approval for the digital medical device product is even more meaningful as it proves that DCT can be sufficiently applied in the domestic healthcare industry field." He added, "Based on our corporate philosophy of prioritizing customer value, J&P Medi will lead the activation of the domestic DCT market by creating various success cases to actively introduce DCT to related domestic institutions and industries struggling with clinical delays."

This content was produced with the assistance of AI translation services.