Five years ago, I began my journey in the clinical trials field. Since then, I have closely followed the evolution of the clinical research landscape across Southern Europe. Over this time, I have observed how countries in this region have strengthened their regulatory frameworks, increased investment in research and development, enhanced investigator capabilities, and gained greater international visibility. As a result, they are becoming increasingly attractive destinations for global clinical trial development.
Beyond their cultural and geographic appeal, these countries demonstrate that strong collaboration across scientific, clinical, and business ecosystems can drive meaningful success in clinical research.
Through market analysis and industry engagement, including scientific publications and conferences, I have identified several key factors that explain why Portugal, Spain, and Italy are compelling locations for conducting clinical trials.
Portugal: An Emerging and Agile Clinical Research Hub
Portugal is demonstrating growing ambition in clinical research, supported by recent investments and infrastructure development. The country is positioning itself as a competitive and dynamic environment for clinical investigations due to:
- Integrated healthcare and research networks: Strong collaboration between hospitals and academic institutions with robust technical capabilities and access to diverse patient populations.
- Regulatory agility: Improvements in regulatory timelines through updated clinical trial legislation aligned with EU standards, streamlined contracting processes, and reduced administrative burden.
- Highly skilled talent: Well-trained investigators, clinicians, and clinical trial professionals with internationally recognized expertise, enabling efficient and high-quality study execution.
- Distributed life-science ecosystem: Activity spread across key hubs such as Lisbon, Porto, Braga, Coimbra, and Cantanhede, fostering innovation, industrial capacity, and investor connectivity.
Spain: A Global Leader in Clinical Research
Spain is widely recognized as one of the world’s leading countries for clinical research and continues to attract investment across biotechnology, pharmaceuticals, and medical technologies. This position is supported by:
- Strong national R&D strategy (2024–2028): Focus on priority therapeutic areas such as oncology, rare diseases, precision medicine, and advanced therapies, aligned with global development pipelines.
- High-quality public healthcare system: Renowned hospitals with extensive clinical research experience.
- Highly qualified investigators: A strong network of experienced professionals capable of delivering complex and large-scale trials with high operational standards.
Italy: A Mature and High-Value Clinical Research Environment
Over the past decade, Italy has developed a robust and mature clinical research ecosystem. According to the study “Tracking a Decade of Phase I Clinical Trials in Italy: Trends and Insights from National and European Registries amid Regulatory Change” (August 2025), Italy has established itself as a key hub for early-phase clinical development.
This strength is supported by:
- Extensive experience in early-phase trials: A solid network of investigators and clinical sites with a strong track record in Phase I studies.
- Leadership in oncology research: Oncology remains a dominant therapeutic area within Italy’s clinical trial landscape.
- Regulatory improvements: Reforms led by AIFA have significantly streamlined ethics and regulatory review processes, accelerating approval timelines, enhancing transparency, and increasing overall attractiveness for sponsors and CROs.
How Linical Can Support Your Clinical Trials in Southern Europe
If you are considering conducting your clinical trial in Southern Europe, Linical offers comprehensive, integrated drug development and lifecycle management services—from early-phase studies through late-phase development.
Our services include:
- Feasibility and study start-up
- Project management
- Clinical monitoring
- Regulatory affairs
- Clinical data management and biostatistics (Biometrics)
- Medical Monitoring
- Pharmacovigilance
- Medical writing
- Quality assurance
Our expert teams bring strong scientific and operational expertise across a broad range of therapeutic areas, including:
- Oncology
- Neurology
- Immunology and vaccines
- Endocrinology and metabolic diseases
- Rare diseases
We also ensure project team continuity, enabling seamless transitions between study phases and maintaining consistency in execution, communication, and quality.
In summary, Southern Europe is no longer an emerging option; it is a strategic choice for sponsors seeking quality, efficiency, and innovation in clinical research. With the right partner, such as Linical, organizations can fully leverage the region’s strengths to accelerate their development programs and deliver value globally.
References
- Article: 06/04/2026: Portugal’s biotech industry is growing up", published by European Biotechnology Magazine, Joachim Eeckhout: Portugal’s biotech industry is growing up - European Biotechnology Magazine
- Conference: 5º Encontro Nacional de Investigacion Clinica e Inovação Biomedica, Faro
- España, líder en investigación clínica de medicamentos – 09/01/2025
- Estrategia_de_la_industria_farmaceutica.pdf
- Spain Aims to Position Itself Among the Top Five Life Sciences Markets in Europe | ES | Cushman & Wakefield
- Tracking a decade of phase I clinical trials in Italy: trends and insights from national and european registries amid regulatory change - PMC
Author:
Margarita Blazquez
Director, Business Development