Monsenso is ISO 13485 certified

Monsenso is ISO 13485 certified

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, Monsenso holds the ISO 27001 certifications, a TGA 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

The use of digital health technologies in clinical trials

The use of digital health technologies in clinical trials

The use of digital health technologies in clinical trials has increased considerably during the last few years, partly to the popularity of wearables such as Apple watches and Fitbit devices, in addition to the many over-the-counter devices and sensors.

In 2000, only eight clinical trials used digital health technologies to assist the trial; however, by 2017, the numbers had increased to 1,100 trials[1]. It has been estimated that by 2025, 70% of clinical trials will incorporate digital sensors[2].

In 2020, the COVID-19 pandemic has further forced adoption of digital health technologies in the healthcare and pharmaceutical industries to protect participant safety and enable clinical trial continuity[3]. 

Modernising clinical trials

According to a study conducted by the Deloitte Centre for Health Solutions the return of investment for R&D in the pharma industry has decreased from 10% in 2010 to 1.8% in 2019[4]. This drives a need for biotech and pharmaceutical companies to transform their R&D models to improve productivity and stay competitive[5]. Already, many have started to shift from traditional trial models to more agile, patient-centric processes by adopting digital health technologies to improve patient engagement during clinical trials and to capture a more rich set of data by incorporating real-world data collection[5]. 

Real-world data is information captured as a “by-product of everyday patient care”, and it can be collected from different sources, such as electronic health records, patient registries, wearables, and the sensors in smartphones[6]. 

Some of the most common digital health technologies adopted by pharmaceutical companies for clinical trials fall into several categories[3]:

  • Telemedicine
  • Electronic informed consent (eConsent)
  • Digital data collection tools
  • Remote site monitoring
  • Direct to patient shipping (DtP)
  • Medication reminders

Besides accelerating and simplifying the clinical trial process, these tools help automate the quantity, quality, and frequency of data collection. 

When implemented together, digital solutions have the potential to do the following[3]:

  • Recruit a more geographically diverse participant population.
  • Ensure trial product availability for participants.
  • Reduce the burden of clinical trial participation.
  • Reduce the number of essential personnel needed at the study site.
  • Automate the collection of data while maintaining levels of quality for submission to health authorities.
  • Improve the efficiency of clinical trials leading to better decisions and reduced timelines.
  • Further advance the concept of risk-based approaches, focusing on the critical study elements that have been stated via health authorities and the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use’s Good Clinical Practice standards.
  • Synthesise real-world evidence (RWE) and digital biomarkers which could be more responsive to change, increasing the possibility of real-time decision-making and benefiting patients enrolled in trials.

There is also an opportunity for greater efficiency by establishing interoperability of EDC systems, electronic health records (EHRs), and digital data collection tools to reduce the amount of source data verification (SDV) required by study monitors. This would mean that a more significant portion of the data could be accessed and reviewed without human transcription and a minimum risk of misinterpretation[3].

Incorporating these technologies into clinical research at every phase opens the possibility for reduced timelines and cost savings. Consequently, it is expected that companies willing to invest in digital technologies may win market share, while those who fall behind may find themselves at a disadvantage[5]. 

consumer readiness 

Digital technologies are embraced by people of all ages, in fact, a 2019 report conducted by Provision Living, a senior living community in the U.S.,  revealed that on average, Baby Boomers (born between 1946 and 1964) and millennials (born between 1981 and 1995) spend on average, five hours a day on their smartphones.

A survey conducted by Rock Health revealed that:

  • 44% of the respondents tracked a health indicator using a digital tool in 2019, an increase from only 33% in 2017.
  • 56% of the respondents shared health tracking data with their physicians in 2019, in comparison to only 46% in 2017.

Monsenso as a companion device, that supports medical compliance

Monsenso is a digital health technology that enables secure real-world data collection and behavioural data tracking via a smartphone app for users/patients and a web portal for clinicians/investigators. The solution is technically and clinically validated, and it can help improve outcomes on clinical trials. 

To learn more about the different clinical studies and clinical trials that have included the Monsenso mHealth solution, visit our Resource Library.

 

References:

    1. Marra, C., Chen, J.L., Coravos, A. et al. Quantifying the use of connected digital products in clinical research. npj Digit. Med. 3, 50 (2020).
    2. Jansen, Y. and Thornton, G. (2020) Wearables & Big Data In Clinical Trials — Where Do We Stand? Clinical Leader 
    3. Beyond COVID-19: Modernizing Clinical Trial Conduct
    4. Steedman, Mark, et al. (2020). Ten years on: Measuring the return from pharmaceutical innovation 2109. Deloitte Centre for Health Solutions.
    5. Digital endpoints whitepaper. Navigating the shift from traditional trial models to agile, patient-centric processes driven by digital health technologies.
    6. Real-world data: how can it improve clinical trial outcomes?

 

Quality Assurance Engineer

Quality Assurance Engineer

Innovative and ambitious mobile health company seeks ambitious QA Engineer to support our continuing growth

MONSENSO is a passionate team dedicated to designing innovative mobile health (mHealth) technology that helps people, care providers and societies overcome the burden of mental illness. 

Modern mobile and cloud-based technologies lies at the root of the company, which was founded on the idea that large-scale collection and analysis of data can be used to provide patients, clinicians and researchers with a detailed and unique insight into mental health.

We are looking for an ambitious Quality Assurance (QA) Engineer to engage in the development of the Monsenso mHealth platform. As a QA Engineer, you will be responsible for the entire quality assurance of the products  – from planing, creating and managing the overall Quality Planning strategy to executing automatic and manual testing. 

You will be a part of our growing team of software developers, and we are looking for people with technical experience as a software developer or QA engineer. You should have experience applying agile software development processes as well as state-of-art quality assurance methodology and technology. 

Key responsibilities

As a QA Engineer, you will have the following responsibilities:

  • Test current products and identify deficiencies
  • Setup, maintain, and develop automatic testing
  • Plan, conduct, and execute usability testing
  • Investigate product quality in order to improve customer satisfaction
  • Be part of the Product Development team to ensure continous QA
  • Identify key KPIs for product quality
  • Prepare and present reports and metrics to Senior Management

Monsenso is a CE marked medical device and complies to high quality standards, including the ISO 13485 and ISO 27001 standards. QA will be part of the overall QA processes in Monsenso. Monsenso applies a high degree of automation in QA using a suite of unit testing, integration testing, and end-to-end testing technologies. We are agile in our software development and QA processes and use scrum-based methods.

What we offer

We offer a fantastic opportunity to join a young and innovative growth company, where you have the ability to make an impact and help shape the future in an exciting field. Personal health technology and mHealth are booming markets worldwide, and you will be at the center of this technology revolution. Mental health is a major burden for society needing new solutions and ways of supporting treatment, and you will contribute to reducing this burden for the benefit of society and the people affected. You will also have the opportunity to work with cutting edge mobile, cloud, and data science technology.

You should expect an informal, fast-paced environment with tremendous opportunities for personal development.

If you have any questions, please contact;

Desired Skills and Expertise

We expect the successful candidate to:

  • Hold a bachelor or master degree in computer science or software engineering.
  • Have solid experience with a variety of different testing techniques such as UI Testing, Automated Testing, Security Testing, and Test Driven Development Strategies.
  • Have concrete and hands-on experience with test automation techniques and tools.
  • Have knowledge and experience of Scrum-based agile development
  • Be a highly structured person and critical thinker with problem-solving skills and sense of details.
  • Have good communications skills – orally as well as in writing. 
  • Take ownership of complex tasks and be a strong self-motivator.
  • Be fluent in English and German, Spanish, French, Swedish or Danish.

As a person, you thrive in a challenging environment, where you can see and influence the bigger picture. You bring a positive mindset and winning attitude, and you see the opportunities in all the things that are not yet in place in a young, growth company compared to an established corporation. 

Apply for this exciting position now!
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Consultant Magnus Bergstrand Wedel on tel.: +45 51 60 72 83. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.

A smartphone app that supports online therapy

A smartphone app that supports online therapy

Monsenso offers a smartphone app that supports online therapy by enabling users to share valuable health data with their therapists in real-time.

What is online therapy used for?

Online therapy, also called e-therapy or teletherapy has many advantages and it gives users access to therapy services offered by mental healthcare providers from the comfort of their home. Therapists can use one of the many secure platforms available to connect with their patients through video conference, phone calls or chat functionality.  It also helps reach people who have very busy schedules and can’t spare the commute, or those are not too comfortable with face to face appointments.

Online therapy can be effective to treat many mood and behavioural disorders such as depression, anxiety, bipolar disorder and borderline personality disorder.  In fact, according to research led by McMaster University online therapy can be more effective than in person.

Just as in traditional therapy, it is important that the goals of online therapy are created by both, the therapist and the client.

Online Cognitive Behavioural Therapy

Cognitive behavioral therapy (CBT) is a tool used to treat a number of mental and physical health issues, and due to its flexibility, CBT online offers many of the benefits found in the face-to-face model. CBT is widely available online, so people experiencing unwanted symptoms linked to anxiety, depression, and other conditions should view it as a viable option to treat their overall well-being.

Online Dialectical Behavioural Therapy

Dialectical Behavioural Therapy (DBT)  is a type of therapy that primarily involves skills training such as mindfulness, emotional regulation, and distress tolerance to assist individuals to better manage emotional distress. It also provides problem-solving strategies to identify and alter harmful behaviors and replace them with constructive ones.

An app that supports online treatment

Before using the Monsenso smartphone app to support his therapy, Peter Hagelund, followed the typical therapeutic setting. His psychiatrist would schedule an appointment every two-three weeks, and they would discuss Peter’s previous weeks.  On most occasions, Peter would say that he had been doing fine, but sometimes he forgot important details that he wanted to discuss.

Now, instead of relying on Peter’s memory during the consultation, his psychiatrist can access his data and see how he has been doing, as it happened. He can view how much he has sleept, how much he exercises, how much he drinks, the levels of anxiety he has, and other relevant aspects to his treatment and his disorder.

Mads Trier-Blom, another Monsenso user, said that the app helps him to be more connected with his clinician, Bente, who intervenes when she can see that he is not feeling well, to help him avoid having an episode.

Psychiatrist Kristoffer Södersten from PsykiatriResurs in Sweden says that the accuracy from a diagnosis obtained can very much depend on many factors such as cultural background and how comfortable the patient is in the conversation. Therefore, it can be very arbitrary the diagnosis a patient receives.

The information gathered from the Monsenso smartphone app helps him get a consistent and clearer view of an individual’s mental health. He finds the Monsenso mHealth solution to be particularly helpful in capturing relevant objective data. The solution provides a comprehensive and easily accessible overview of relevant patient data, such as the individual’s overall day score, his mood, the number of hours he slept, and if he took his medication.  The smartphone app also collects sensor data, such as physical activity, social activity, phone usage and voice features which helps to supplement the subjective data provided.

The Monsenso mHealth solution has helped mental healthcare providers to get an overview of an individual’s historical data and correlation analysis. It also helps them identify the triggers and early warning signs everyone has, enabling them to intervene at an early stage before they have an episode, such as in the case of Mads.

Besides, the smartphone app helps users to be more aware of their mood, their symptoms and the reason why these symptoms appear. It also provides them with useful skill-training content to help them deal with stressful situations.

A smartphone app that can help psychiatrists diagnose mental illness

A smartphone app that can help psychiatrists diagnose mental illness

“A smartphone app that can help psychiatrists diagnose mental illness” –  Peter Hagelund, a Monsenso user, speaks about his experience using the Monsenso mobile health solution to support his treatment, and how it has helped  him improve the communication with his psychiatrist.

Prior to using the Monsenso smartphone app, Peter and his psychiatrist followed the typical therapeutic setting, they would schedule an appointment every two-three weeks, and they would have a conversation to discuss Peter’s previous weeks.  Peter would usually say that he had been doing fine for each appointment, but sometimes he forgot important details that he wanted to discuss.

“It can be pretty tricky to remember, two weeks later [between appointments] how you actually felt that day. With the app it’s really easy to go back and see if your mood has been pretty stable over the last two months, or if you had had some ups and downs over a period,” says Peter Hagelund.

Now, instead of relying on Peter’s memory during the appointment, his psychiatrist can access his data and see how he has been doing, as it happened. He can view how much he has been sleeping, how much he exercises, how much he drinks, how much anxiety he has, and other relevant aspects to his treatment and his disorder.

“My psychiatrist now says things like You say you’ve been doing fine, but I can actually see that you’ve had a few ups and downs. I think the app helps him get a real view of how I have been doing,” says Peter Hagelund.

In his Danish documentary series “Jeg savner min sygdom” (which translates to “I miss my illness”), Peter Hagelund talks about his experience of getting the wrong diagnosis and how finally after six years he got the right diagnosis and treatment. 

In 2014, he was diagnosed with Bipolar Disorder Type 2.

During his whole life, he knew there was something different about him. He always struggled with depression and anxiety, and what eventually turned out to be hypomania. When he was 22, he had his first big episode of depression and began taking antidepressants. However, it took six more years before he was officially diagnosed with Bipolar Disorder Type 2.

He says that one of the trickiest things about having this diagnosis is that he does not experience the typical manic episode where a person feels over-energetic and nearly psychotic. Instead, he feels hypomanic, which means that he is socially well functioning. He is not psychotic. He just feels really well; the problem with this, was that he didn’t feel the need to inform his psychiatrist the fact that he was feeling too well

His psychiatrist found out that he had Bipolar Disorder was because he couldn’t come out of his depression. At first, he was diagnosed with depression and ADD. But these diagnoses didn’t seem to fit because he still had strong mood swings and a lot of anxiety. When he was diagnosed with Bipolar Disorder Type 2, it actually made sense to him. Suddenly, he could see why he had felt the way he had most of his life.

“I really believe that the Monsenso smartphone app could have helped my psychiatrist give me the right diagnosis at an earlier stage because the app helps me to keep track of my mood and to become more aware of how I feel. With the app, I have to pause and take a moment to think about how I’ve actually been doing before entering my answers. Keeping track of all this information has helped my treatment. My psychiatrist and I can plan better on how to avoid my future depressive or hypomanic episodes because we can clearly identify when I am having mood swings”. says Peter Hagelund.  

In August 2018, his documentary about living with Bipolar Disorder aired on national Danish television and the response was overwhelming. Many people contacted him, to thank him for talking about his illness. He made the documentary so other people who have this illness, do not feel ashamed of it.

“My hope is that in the future people are diagnosed at an earlier stage than I was and I truly believe the Monsenso app is one of the things that can help. I really hope that other psychiatrists and their patients will start using the app,” he added.

Click here to read this story in Danish.