JNP Medi-Welt Collaborate to Apply Decentralized Clinical Trials to Digital Therapeutics

[Asia Economy Reporter Kim Young-won] J&P Medi announced on the 19th that it will apply its self-developed decentralized clinical trial (DCT) solution, 'Maven DCT Suite,' to the confirmatory clinical trial of Welt's digital therapeutic (DTx) for insomnia.

J&P Medi explained that the Maven DCT Suite possesses advanced technology, including convenient data collection for subjects, highly accurate analysis precision, an optimized interface, and high reliability based on blockchain technology.

This application of DCT for insomnia DTx will be conducted in collaboration with Yonsei University Severance Hospital in Sinchon. The entire preclinical process, where the DTx application developed by Welt is installed on smartphones and monitored by researchers, will be carried out through the Maven DCT Suite.

Clinical trial participants will be recruited via social networking services (SNS) and undergo a screening process to determine eligibility. Most processes, such as eConsent (electronic Informed Consent) for electronic consent and eCOA (Clinical Outcome Assessment) for collecting clinical data using mobile devices, will be conducted remotely, minimizing hospital visits.

DCT is a method of conducting clinical trial processes remotely, from participant recruitment, consent, data collection, monitoring, to prescription, which is expected to shorten clinical trial periods, reduce costs, and increase accuracy.

Kang Sung-ji, CEO of Welt, said, "Digital therapeutics are living treatments where patients input data directly and clinicians monitor in real time. J&P Medi's DCT solution will continue to be used for product management even after approval and was adopted because it is expected to reduce local clinical costs and accelerate trial speed when expanding overseas."

Jung Kwon-ho, CEO of J&P Medi, stated, "This case will serve as an opportunity to demonstrate that DCT is sufficiently applicable domestically and to raise awareness among all clinical trial stakeholders about its effectiveness. As the wave of change in clinical trials through digital technology is essential, we will continue to prove this through various DCT application cases."

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