Insight

Denmark’s fast-track model drives surge in Phase I clinical trial applications

Insight

Denmark’s fast-track model drives surge in Phase I clinical trial applications

Denmark continues to strengthen its position as one of Europe’s leading destinations for clinical research. A new accelerated approval process, close collaboration between authorities and research environments, and a single national entry point for sponsors are making it faster and easier to bring early-stage studies from protocol to patient.

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What makes Denmark a leading location for clinical trials?

Denmark combines strong clinical research environments with a highly digitalised and collaborative healthcare system.

According to the Danish Medicines Agency, Denmark already conducts more clinical trials per capita than any other EU country. Recent initiatives aim to maintain this position and attract a larger share of global early-stage research.

Denmark’s Life Science Strategy towards 2030, reflects a political commitment to strengthening the conditions for research, innovation and investment. For clinical trial sponsors, the strategy has translated this ambition into concrete measures, including the 14-day review process for eligible Phase I trials, further development of Trial Nation  as a national entry point and initiatives to improve clinical research and access to health data. 

For international pharmaceutical and biotechnology companies, some of the main advantages include:

  • A 14-day review process for eligible Phase I and integrated Phase I/II trial applications
  • A coordinated regulatory and ethical assessment
  • Experienced early-phase clinical research units
  • Nationwide health data and digital infrastructure
  • Strong public-private collaboration
  • A population with a high level of trust in healthcare and research
  • One national entry point through Trial Nation

Phase I applications have nearly doubled

Since autumn 2025, eligible Phase I trial applications have been reviewed within 14 days, supporting one of the ambitions of Denmark’s national Life Science Strategy. For companies, the accelerated process means greater predictability at a critical stage of clinical development. Regulatory and ethical assessments are coordinated and prioritised, reducing idle time while maintaining the same requirements for scientific quality, ethics and patient safety.


Applications for Phase I clinical trials in Denmark increased by almost 80 percent during the first six months of 2026 compared with the same period in 2025, indicating growing confidence among sponsors in Denmark as a reliable location for early-stage clinical research.


Choosing Denmark for a Phase I study can also support a sponsor’s longer-term development programme. Strong research environments, experienced trial units and close dialogue with authorities can provide a solid foundation for later clinical phases and broader European activities.


“The rise in Phase I applications shows that sponsors have confidence in Denmark as a trusted and predictable environment for early clinical development. When companies choose to place these important first studies here, it reflects trust in our authorities, research environments and ability to deliver high-quality clinical trials.”


Nils Falk Bjerregaard
Director General, Danish Medicines Agency

Life Science Clinical Trials

Collaboration creates speed and predictability

The fast-track model builds on close cooperation between the Danish Medicines Agency and the Medical Research Ethics Committees. A clear division of responsibilities and a coordinated list of questions for sponsors help avoid duplicate processes and create greater predictability.

Companies can also engage directly with the authorities before and during the application process. This pragmatic approach is particularly valuable for first-in-human studies, advanced therapies, complex protocols and studies combining medicinal products with medical devices.

One national entry point for trial sponsors

Trial Nation provides international companies with a single national entry point to Denmark’s clinical research ecosystem. Its free services include access to established clinical networks and a coordinated feasibility process, with a consolidated feasibility response from relevant Danish hospital sites within five working days.


Trial Nation connects sponsors with researchers, hospitals, patient organisations, and specialised clinical environments across all therapeutic areas including oncology, haematology, dermatology, paediatrics, respiratory diseases, infectious diseases and dementia.


“For sponsors, Denmark offers a streamlined route from initial feasibility to study start-up. Through one national entry point, companies can quickly identify relevant investigators and trial sites, receive coordinated feedback and access an experienced clinical research ecosystem.”

Marianne Pilgaard
CEO, Trial Nation

From around the world to Danish study sites

Through its international network, Invest in Denmark provides pharmaceutical and biotechnology companies with tailored support, easing the path to initiating clinical trials in Denmark.

Invest in Denmark is also very pleased to connect with pharmaceutical and biotechnology companies at major international medical conferences. These meetings create an opportunity to discuss upcoming development pipelines, identify studies that match Danish clinical capabilities and establish direct connections with relevant Danish investigators and trial units.

“Our life science experts across North America, Europe and Asia provide tailored support to meet each sponsor’s specific needs. We assist companies of all sizes, from emerging biotechs preparing their first clinical development programme to multinational pharmaceutical companies managing global portfolios.”

Tine Hartman Nielsen
Team Lead Life Science, Invest in Denmark  


Together with Trial Nation and clinical partners, Invest in Denmark can subsequently help facilitate focused meetings, feasibility assessments and visits to Denmark.

Invest in Denmark provides confidential and free assistance with:

  • Assessing Denmark as a potential trial location

  • Identifying relevant clinical sites and research environments

  • Providing regulatory and market insights

  • Facilitating contact with the Danish Medicines Agency and Trial Nation

  • Introducing companies to investigators, hospitals and key opinion leaders

  • Organising tailored visits to Danish clinical research facilities

  • Supporting the development of long-term clinical and commercial partnerships

Planning clinical trials in Europe?

Whether your company is preparing a first-in-human study or expanding a global clinical development programme, Invest in Denmark can help you assess the opportunities in Denmark.


Our services are free of charge, confidential and tailored to your development strategy. Contact our international life science team to explore relevant clinical sites, investigators and next steps.