First Participant Recruited in PhaseV Study on Chronic Spontaneous Urticaria

First Participant Recruited in PhaseV Study on Chronic Spontaneous Urticaria

Aug 20, 2025

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.

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The Power of Citizen-Generated Health Data – a Business Review Life Science Podcast

The Power of Citizen-Generated Health Data – a Business Review Life Science Podcast

Aug 4, 2025

Copenhagen, Denmark 

Monsenso is happy to announce that our CEO, Thomas Lethenborg, recently participated in the Business Review Life Science podcast, joining a compelling panel discussion on the transformative potential of real-world patient-reported data.

The episode, titled “Borgernes egne sundhedsdata” (“Citizen-Generated Health Data”), will be aired on August 11th and features key voices from the ongoing Phase V innovation project.

Hosted by Heidi Bendtsen Nielsen, the podcast explores how personal health data – such as information collected via smartphones, blood pressure monitors, or smartwatches – can be used to enhance treatment outcomes, support prevention, and relieve pressure on healthcare systems.

Thomas Lethenborg was joined by:

  • Frederik Knud Nielsen, Healthcare Partnership Director at Novartis
  • Frederik Mølgaard Thayssen, Principal Project Manager at the Alexandra Institute

Together, the panel addressed several timely and critical questions:

  • What opportunities do Danes have today to collect and contribute their own health data?
  • How can these data be validated and effectively integrated into healthcare practices?
  • What barriers – regulatory, ethical, or technical – still need to be overcome?
  • How can public-private collaborations, like Phase V, unlock the full potential of data-driven healthcare?

“At Monsenso, we see real-world data as a key enabler of more personalised, preventive, and efficient healthcare”, said Thomas Lethenborg. “This podcast gave us a great platform to highlight not only the technological possibilities but also the importance of patient involvement and responsible data use.”

The discussion also emphasised the need for stronger political commitment to support personalised, data-driven innovation in healthcare and showcased examples of successful collaborations between industry and the public sector – including the Phase V initiative.

Listeners can access the full episode (in Danish) on the Business Review Life Science platform.

To learn more or explore a pilot or integration, book a demo or get in touch via our website.

 

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Monsenso supports UK research on treatment-resistant depression

Monsenso supports UK research on treatment-resistant depression

Jul 24, 2025

Copenhagen, Denmark

Monsenso delivers digital research platform for groundbreaking UK project on treatment-resistant depression.

Monsenso A/S is proud to announce its strategic role as the digital technology partner for the DECODE project in the United Kingdom. The initiative, led by the University of Birmingham, in collaboration with the Mental Health Mission Midlands Translational Centre, Birmingham and Solihull NHS Foundation Trust, and Nottinghamshire Healthcare NHS Foundation Trust, is focused on transforming clinical research and care for patients with treatment-resistant depression (TRD).

As part of the project, Monsenso’s digital platform will enable stratified recruitment, remote data collection, and standardised clinical endpoint measurement across multiple NHS sites — laying the groundwork for improved precision in depression research and future interventions.

Addressing a Critical Public Health Challenge

Treatment-resistant depression (TRD) affects almost half of patients diagnosed with major depressive disorder meaning they do not respond to two or more oral antidepressants, and TRD is associated with poorer outcomes, including high comorbidity, suicidality, and economic burden. 

The DECODE project aims to build a digitally enabled recruitment and monitoring infrastructure to better identify, understand, and ultimately treat this complex condition.

Recruitment is expected to begin in Q3 2025, with Monsenso’s platform playing a pivotal role in data collection and patient stratification.

Quote from Monsenso CEO

“We are honoured to support such an important national initiative addressing one of the most challenging areas in mental health. Monsenso’s platform is designed to help healthcare providers and researchers make better, data-driven decisions through real-time digital monitoring and standardised assessments,” said Thomas Lethenborg, CEO of Monsenso.

“This project reaffirms our strategic positioning as a trusted partner in supporting decentralised, real-world data studies across Europe with healthcare, academic institutions and pharmaceuticals.”

Strategic Importance for Monsenso

  • Expansion into the UK: Strengthens Monsenso’s footprint within the UK healthcare ecosystem, particularly within the NHS and leading academic partners.
  • Scalable digital, decentralised research model: Demonstrates the scalability and flexibility of Monsenso’s platform for decentralised multi-site health research.
  • Expansion possibilities: If successful, the DECODE project has potential to pave the way for geographic expansion and follow-on precision-medicine studies.
  • Validation of product-market fit: Reinforces Monsenso’s role in delivering regulated, patient-centric digital tools that meet the complex needs of decentralised, real-world studies in psychiatric conditions and beyond.

Academic and Clinical Endorsement

Professor Steven Marwaha, Co-director of the Midlands Mental Health Mission and Professor at the University of Birmingham, stated:

“This partnership with Monsenso enables us to streamline and enhance the way we recruit patients and assess outcomes. By integrating continuous data collection, digital phenotyping tools and standardising clinical endpoints, we can accelerate our understanding of treatment-resistant depression and drive more precise and personalised future interventions.

Click the button below for more information about the Monsenso solution.

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Monsenso successfully completes ISO 13485 re-certification audit

Monsenso successfully completes ISO 13485 re-certification audit

Jul 7, 2025

Copenhagen, Denmark 

Monsenso is proud to announce the successful completion of its ISO 13485 re-certification audit, reaffirming our commitment to the highest standards of quality and safety in the development of digital health solutions for mental health.

ISO 13485 is the internationally recognised gold standard for medical device companies, ensuring that products consistently meet customer requirements, regulatory expectations, and the highest levels of safety and efficacy. The re-certification confirms that Monsenso’s Quality Management System (QMS) continues to meet stringent requirements specific to the medical device industry.

“Ensuring quality and compliance is at the heart of what we do. Our ISO 13485 re-certification underscores our dedication to delivering safe, effective, and reliable solutions that healthcare providers and patients can trust,” says Thomas Lethenborg, CEO at Monsenso.

This achievement reflects Monsenso’s ongoing efforts to provide secure, clinically validated mobile health solutions that empower patients, support clinicians, and strengthen health services worldwide.

For additional information, please contact:

Nanna Iversen

Chief Operating Officer

iversen@monsenso.com

+45 27267120

To learn more or explore a pilot or integration, book a demo or get in touch via our website.

 

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Participant Recruitment Begins for MENTBEST Research Project in Denmark

Participant Recruitment Begins for MENTBEST Research Project in Denmark

Jun 19, 2025

Copenhagen, Denmark 

We are excited to announce the launch of participant recruitment for the Danish arm of the European research project MENTBEST. The project is now seeking individuals to join a new study led by the Copenhagen Affective Disorder Research Center at Psychiatric Center Copenhagen, Region Hovedstadens Psykiatri.

About the Study

The aim of the study is to explore how a digital app can support individuals in managing depressive symptoms. As part of the larger MENTBEST initiative, this research trial will contribute to the development and validation of a personalised, AI-enabled self-care programme built on Monsenso’s digital health platform.

Who Can Participate?

We are looking for individuals who are currently experiencing depressive symptoms or who have previously been diagnosed with depression.

Common symptoms include:

  • Persistent sadness
  • Reduced interest or pleasure in activities
  • Lower energy levels
  • Difficulty concentrating or making decisions
  • Fatigue and disrupted sleep
  • Changes in appetite

If this sounds familiar and you are interested in contributing to mental health research, we would like to hear from you!

About MENTBEST

MENTBEST (Mental Health Best Practices) – a Horizon Europe project funded by European Commision – is aiming to develop innovative, community-based mental health interventions. It targets vulnerable populations across Europe who are at high risk of developing mental health challenges due to rapid societal change. The project spans five countries: Denmark, Germany, Spain, Ireland, and Greece, and brings together 14 expert organisations under the leadership of the European Alliance Against Depression (EAAD).

The project focuses on delivering scalable, digital, evidence-based tools to strengthen self-help and resilience in the face of mental health challenges. In Denmark, the trial is being conducted in partnership with Monsenso, a digital mental health company, and mental health researchers from Region Hovedstaden.

Contact Information

To participate or learn more, please contact:

Malene Schwarz Dyrehot
 Project Nurse, CADIC
 📞 +45 21 52 34 53
 📧 pck-mentina.region-hovedstadens-psykiatri@regionh.dk

For updates and further information, follow the MENTBEST LinkedIn page.

 To learn more or explore a pilot or integration, book a demo or get in touch via our website.

 

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Personae Project Reaches First Recruitment Milestone in Denmark

Personae Project Reaches First Recruitment Milestone in Denmark

Jun 12, 2025

Copenhagen, Denmark 

We are delighted to announce an important milestone for the Personae project: On June 11, the first patient was enrolled in the Danish study at Center for Digital Psychiatry at Region South Denmark.

About the project

Personae is a research and innovation initiative supported by Innovation Fund Denmark. It develops and evaluates AI-enabled blended care for mental health by combining smartphone technology, patient-reported outcomes, and internet-based cognitive behavioural therapy (iCBT) to tailor treatment to the individual, with a particular focus on depression.

COLLABORATION

The study is led by the Copenhagen Affective Disorder Research Center (CADIC) at Psychiatric Center Copenhagen, Region Hovedstadens Psykiatri, in close collaboration with Monsenso, and brings together additional partners from Denmark and Ireland: the University of Limerick (D²iCE), the Centre for Innovative Medical Technology (CIMT), and Depressionsforeningen.

This first recruitment marks an exciting step forward in realising the project’s ambitions to deliver scalable, digital, evidence-based solutions that strengthen access to mental health care across Europe.

For more information about the project and its progress, visit the Personae website or follow Monsenso on LinkedIn.

 To learn more or explore a pilot or integration, book a demo or get in touch via our website.

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