Copenhagen, Denmark
We are pleased to share a new milestone from the national cross-sector innovation programme, PhaseV, supported by Innovation Fund Denmark. The project is pioneering a digital-first approach to decentralised, real-world clinical studies across several disease areas.
The Work Package 6 (WP6) study, focusing on chronic spontaneous urticaria (CSU), has successfully recruited its first participant. This marks the beginning of an important research effort that will explore how digital tools can support patients and clinicians in monitoring symptoms and treatment over time.
ABOUT THE PROJECT
The CSU study aims to develop and validate novel digital assessment tools that use patient-submitted photographs and questionnaires to remotely track urticaria severity in daily life. In addition, the study will explore how lifestyle and environmental factors (such as activity and sleep) influence CSU symptom flares, and will test new methods for conducting decentralised clinical research, including remote informed consent.
In PhaseV, participants use connected devices and a study app developed by Monsenso to report patient-generated health data from home. Clinicians can access these data through a dedicated web portal, helping to bridge the gap between daily life and the clinic.
The Urticaria study is one of three studies within PhaseV, alongside studies in obesity and diabetic foot ulcers, all aiming to demonstrate how decentralised designs can make clinical research more efficient, patient-friendly, and closer to real-world practice.
We look forward to following the progress of the CSU study and the insights it will generate for the future of clinical research and patient care.
Private-PUBLIC partnership
The consortium is led by Monsenso and includes partners across academia, healthcare, industry, and innovation: Aarhus University, Research Unit for General Practice (FEAP), Bispebjerg Hospital, Steno Diabetes Center Aarhus, Aarhus Municipality, the Danish Technological Institute, the Alexandra Institute, the Copenhagen Institute for Futures Studies, Danish Life Science Cluster, Novo Nordisk, and Novartis.
PhaseV aims to deliver a scalable digital platform for effective decentralised recruitment, continuous data capture, and phase-V style real-world studies that can strengthen patient care and decision-making.
For more information about the project and its progress, visit the PhaseV website or the Danish Life Science Cluster project page, or follow Monsenso on LinkedIn.
To learn more or explore a pilot or integration, book a demo or get in touch via our website.