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.

Solution
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.

 

Solution
Monsenso completes ISO 27001 surveillance audit

Monsenso completes ISO 27001 surveillance audit

May 13, 2025

Copenhagen, Denmark 

Monsenso is pleased to announce the successful completion of its ISO 27001 surveillance audit, further validating our commitment to world-class information security.

ISO 27001 is the leading international standard for information security management systems (ISMS). It ensures that organisations implement comprehensive processes to protect sensitive information, intellectual property, and third-party data in accordance with globally recognised best practices.

The successful audit confirms that Monsenso maintains robust data protection standards, ensuring the confidentiality, integrity, and availability of sensitive health data collected and processed through our platform.

“Data security is a cornerstone of trust in digital health. This audit reaffirms that Monsenso continues to protect user data at the highest level, giving patients, clinicians, and partners the confidence they need to embrace digital mental health solutions,” says Thomas Lethenborg, CEO at Monsenso.

By combining rigorous information security practices with high-quality, clinically validated digital solutions, Monsenso remains committed to supporting healthcare providers and researchers with technology that is not only innovative but also safe and trustworthy.

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.

 

Solution
Monsenso successfully completes ISO 13485 re-certification audit

Monsenso is ISO 13485 certified

Aug 21, 2020

Quality Policy and Standards

As a technology leader in mobile health (mHealth) solutions for mental health, Monsenso is ISO 13485 certified. ISO 13485 is the gold standard for medical device companies to ensure the quality, safety and efficacy of products in the medical device field. This certification ensures that the product in question, consistently meets customer requirements and regulatory requirements applicable to medical devices and other related services.

“Monsenso adheres to the highest security standards. Beyond, being ISO 13485 certified, Monsenso holds the ISO 27001 certification and class 1 CE mark.” says Thomas Lethenborg, CEO at Monsenso.

For additional information contact:
Jennifer Highland
Marketing and Communications Manager
Monsenso
+45 81 71 7713
highland@monsenso.com

Eurostars grants Monsenso major funding for further development

Eurostars grants Monsenso major funding for further development

Jan 31, 2017

Copenhagen, Denmark – 31 January 2017. Monsenso ApS, Region Zealand, and two German partners have been granted major funding by Eureka/Eurostars, for the “IMProving Availability and Cost-effectiveness of mental Healthcare for Schizophrenia through mHealth” (IMPACHS) project.

The objective of the IMPACHS project is to design and develop a mobile and context-aware Cognitive Behaviour Therapy (CBT) content integrated into Monsenso Clinic. Through IMPACHS, Monsenso will deliver smartphone-based intervention technology for outpatients diagnosed with schizophrenia, to improve the availability and cost-effectiveness of mental health care.

Eurostars is the largest programme of knowledge-intensive SMEs with the objective of stimulating growth through international cooperation on the development of new products and services.

With regards to the grant, Thomas Lethenborg, CEO at Monsenso said “This grant will allow us to shift from being a remote patient monitoring digital tool to providing intelligent treatment to individuals with schizophrenia and other mental disorders over time. This will be the third project where we work on a similar solution since RADMIS  and ENTER (previously called E-Mental) have similar goals, but for patients with bipolar disorder and borderline personality disorder respectively.”

The programme is a jointly funded initiative between the EU and 36 Eurostars countries in Europe and around the world, including Canada, South Korea, South Africa, Turkey, and Israel. During the first round of qualifications, there were 370 submissions, from which 61 projects were from Denmark. When the final qualification round took place, 19 Danish projects were selected to receive significant funding.

The Danish Innovations Fund is the local representative of Eureka/Eurostars in Denmark, and its total budget to distribute amongst all Danish projects is 43 million DKK.

For additional information contact:

Jennifer Highland
Marketing and Communications Manager
Monsenso
+45 81 75 80 01
highland@monsenso.com

To read the original press release in Danish issues by the Danish Innovations Fund, click here.

Private Swedish psychiatric clinic adopts mHealth solution for depression treatment

Private Swedish psychiatric clinic adopts mHealth solution for depression treatment

Dec 13, 2016

Copenhagen, Denmark – 13 December 2016. Monsenso, an innovation leader in mobile health (mHealth) technology for mental health, announced today that Psykiatriresurs, a private practice clinic in Gothenburg, Sweden, will implement the Monsenso mHealth solution for depression treatment.

The private clinic, which offers psychological and neuropsychiatric services, provides mental health treatment to 600 individuals with depression, anxiety, personality disorders and ADHD. In addition to these patients,  Psykiatriresurs will soon open a second clinic with a similar capacity, in Varberg, 80 km South of Gothenburg.

To start with, the mHealth solution for depression will be used by 250 patients, although Dr. Kristoffer Södersten, Director of the clinic, has plans to roll it out to all patients across both clinics.

“With this new technology, we want to raise the bar on the mental health treatment offered around the different private clinics in Sweden, and with the Monsenso mHealth solution we will be able to go a step further by reaching out to our patients when they need it the most. At  Psykiatriresurs  we are constantly looking to improve our patients’ experience, and our aim is to use the technology to improve and personalise even more of the treatments we currently provide to our patients,” said Dr. Södersten.

The mHealth solution for depression will be used by the clinicians to support the personalised treatment of individuals with this disorder. With the web portal, they will be able to identify the triggers and early-warning signs of all patients and schedule emergency consultations when needed.

Thomas Lethenborg, CEO at Monsenso, said “With the implementation of the Monsenso mHealth solution for depression, clinicians at  Psykiatriresurs  will have access to real-time patient monitoring and their patients’ historical data, which will help them make better decisions in regards to clinical treatment.”

Patients will use a smartphone app to collect sensor data and fill in routine self-assessments that reveal their current state of mind. The smartphone app also works as a self-management tool that allows patients to manage their symptoms.

Clinicians will use a web portal where they can access all the data collected by the patients’ smartphones, anytime, anywhere. The web portal enables clinicians to view relevant information related to each patient.

For additional information contact:

Jennifer Highland
Marketing and Communications Manager
Monsenso
+45 81 75 80 01
highland@monsenso.com


Kristoffer Södersten
Director
Psykiatriresurs
+46 03 13 13 51 90
kristoffer.sodersten@psykiatriresursigoteborg.se   

You can download this article as a PDF in English, Danish and Swedish