Denmark, The ideal location for clinical trials within medical device and digital health
With increasing digitization of life science products and new IVDR and MDR, the need for clinical trials for medical devices and digital health grows. Denmark is already a European leader in clinical trials for pharmaceutical products, and within the past year, the number of clinical trials for medical devices has doubled.
#1 Reason: Single national entry point
Trial Nation is the single national entry point to clinical trials in Denmark. They work to increase the number and performance of clinical trials and offer guidance for life science companies, patient organisations and clinical researchers wishing to sponsor, participate in or conduct clinical trials in Denmark. Their service is free of charge. Your company can get a wide range of services, including identification of relevant specialists and clinical researchers, access to a legal network and national contract templates, and establishment of partnerships with hospitals, scientists and patient networks. Just to mention a few. Trial Nation also ensures up-to-date and specialized education of healthcare staff running the clinical trials.
The Danish approval time for clinical trials is among the fastest in Europe and the Danish government is working on bringing it down further. The same goes for fees associated with clinical trials.
”Trial Nation continuously support both Sponsors and Clinical Researchers to ensure the best conditions for clinical trials. Our services focus on prompt and comprehensive clinical trial collaborations and are renowned amongst both life science companies and healthcare providers.”
#2 Reason: A national healthcare system and high volume departments
The Danish hospitals are run by public health, which means that Denmark is characterised by a uniform and cohesive healthcare system coordinated and regulated by the central government. Treatment in Denmark is set to meet the same standards regardless of where in the country it takes place. This makes it easier to perform clinical trials from sites in all parts of the country. 99% of the hospital beds in Denmark are found in public hospitals.
The public healthcare system has undergone a centralization, so despite the small population size, each hospital has high volume departments which enables the right number of patients in short time for your trial. Danish patients are known to be some of the best clinical trial subjects and often enrol in trials, when asked, due to high education level and a positive attitude towards research in general.
#3 Reason: A highly digitalised clinical landscape and tech-savvy population
Another fundamental reason for Denmark being the ideal place to perform clinical trials is its highly digitalised clinical landscape. Denmark has one of EU’s most advanced digitalised infrastructures and is a global digital front-runner. A well-functioning digital landscape is essential when performing clinical trials with medical technology as processes are often highly dependent on the use of digital tools. Danish hospitals are technologically agile, which was illustrated by their ability to rapidly implement digital tools in the onset of the COVID-19 pandemic.
“Patients in Denmark have a high level of digital maturity, which has enabled us to conduct clinical trials in Denmark entirely remotely, with patient enrolment through digital tools and data collection via clinical trial apps. Everything runs smoothly and patients are satisfied with the method and their study participation, as the digital approach allows for greater flexibility and remote visits that can be conducted whenever it fits their calendar.”
#4 Reason: Global frontrunner in Decentralised Clinical Trials
Denmark is moving full speed ahead to become a global decentralized clinical trial (DCT) frontrunner. A key to success being the close collaboration between authorities, clinicians, companies, and patients. A central link to this journey is the proactive role of the Danish Medicines Agency, which launched a DCT guideline in 2021. This paves the way for significant collaboration across regulatory and clinical areas, and foreign stakeholder have recognised it broadly. Focused political prioritisation and continuous investments in the area has also contributed to Denmark’s strong position within DCTs.
“The Danish Medicines Agency is committed to driving regulatory innovation that will create value for patients and improve health. Clinical studies are undergoing rapid development towards digitalisation and decentralisation, and the Danish Medicines Agency has initiated an ambitious project to secure a modern and robust regulatory framework for digitalisation and the decentralisation of clinical trials. Denmark is a unique sandbox for decentralised clinical trials, and we have gained a lot of early insights on a national level.”
#5 Reason: World-class Danish health data and data management competences
Danish health data is world-class, and there are unique opportunities to use it for research and development. Danish health data can be used to generate extensive and useful knowledge within both public and private research, innovation, and development to the benefit of patients. The data is longitudinal and linkable from centralized health databases, biobanks and registers from the entire Danish population, including data mining competences to give you unique R&D insights and performance insights on existing products.#6 Reason: A vibrant and mature life science ecosystem with ambitious political strategies
In Denmark, you have
the opportunity to tap into a solid life science ecosystem with global top 20
universities, the right R&D facilities, CE-marking knowhow, CROs,
non-profit research and technology organisation specialised in medtech, ambitious
political strategies, and short distance to authorities – all gathered within a
ratio of 300 km. For years, Denmark has invested heavily in building a solid infrastructure
on all levels to boost the industry. Today, Denmark is reaping the reward as
the life science industry accounts for
more than 20% of Domestic Exports. This makes Denmark the fifth largest global
life science exporter measured per capita. Life science also has a dedicated strategy
with four ministries, business associations and patient organisations working
together to create the best possible framework conditions for the industry and
the Danish society. It is no surprise that Denmark is also the largest
medtech employer in Europe, measured per capita.
“Denmark is an optimal country for doing clinical research within medical technology. Thanks to the strong focus of the Danish government, as well as guidance and collaboration provided by authorities, it is fast and simple to assess the potential for setting up a clinical trial. A digitalised society, the access to data and patients, as well as ease of doing partnerships between the public and private sector make Denmark a very interesting country for Medtronic.”