Reflecting on over four decades in Clinical Research, I have seen the ‘go-to’ countries, regulations, complexity of study design, number of endpoints and technology change study conduct beyond all recognition. Although Europe (all of it) remains a centre of research excellence, it is critical to remind pharma and biotech why it remains the first choice for clinical research.
Spain has established itself as one of Europe’s premier destinations for clinical research, consistently ranking among the continent’s leading countries for clinical trial activity. At Advanced Clinical this success has not been the result of a single factor, but rather a mature and highly coordinated ecosystem built on strong public-private collaboration, experienced investigators, dedicated research units, highly trained study coordinators, academic excellence, and efficient operational infrastructure [1][2].
Over the last decade, Spain has developed a clinical research environment that combines scientific rigor with practical execution. Supported by a universal healthcare system, a highly regarded regulatory authority, and a network of collaborative research organisations, Spain continues to attract global sponsors seeking quality, speed, and reliability in clinical trial delivery.
One of Spain’s greatest strengths is its healthcare infrastructure. The country’s universal public healthcare system serves around 48 million people and is organised across 17 autonomous communities. Despite this, Spain maintains strong national coordination. This structure provides sponsors with access to a large, well-characterised patient population that facilitates consistent clinical practices across healthcare institutions[3][4].
Spain also benefits from a highly educated healthcare workforce. Physicians, nurses, pharmacists, and research professionals benefit from a strong public university system and operate within rigorous professional standards. As a result, many Spanish investigators and study teams have the capabilities and competencies to conduct multinational clinical trials across a broad range of therapeutic areas [5].
Regulatory excellence has also played a critical role. Spain was an early adopter of many principles later incorporated into the European Clinical Trials Regulation through Royal Decree 1090/2015, creating a streamlined and coordinated framework for clinical trial approvals [6][7]. The Spanish Agency of Medicines and Medical Devices (AEMPS) has a well-earned reputation for scientific rigor, transparency, accessibility, and efficient review timelines. The country’s transition from its national submission platform to the Clinical Trials Information System (CTIS) was notably smooth, reflecting the maturity of its regulatory infrastructure [8].
Patient recruitment remains another major advantage. Spanish sites have consistently demonstrated strong enrolment performance, supported by a large and diverse patient population and a culture that is generally receptive to taking part in clinical research. Spain has been particularly active in oncology, rare diseases, paediatric research, and advanced therapies [2][9].
Perhaps most importantly, Spain has developed a uniquely collaborative environment involving regulators, hospitals, universities, research institutes, pharmaceutical companies, CROs, and patient organisations. This coordinated ecosystem has become a defining competitive advantage and a key reason why international sponsors continue to select Spain for strategic clinical development programmes [1][4].
Spain’s rise to leadership in clinical research has been underpinned by a series of deliberate regulatory and institutional initiatives.
The implementation of Royal Decree 1090/2015 anticipated many aspects of EU Regulation 536/2014 and introduced a harmonised approach to trial evaluation, including coordinated ethics review procedures and streamlined authorisation processes [6][7]. These measures significantly improved study start-up efficiency while maintaining high standards of patient protection and scientific quality; putting it ahead of its European partners.
The country has also invested heavily in collaborative research networks. Organisations such as the Spanish Network of Pediatric Clinical Trials (RECLIP), the Spanish National Cancer Research Centre (CNIO), the Spanish Network of Cancer Registries (REDECAN), and the Instituto de Salud Carlos III’s RICORS networks provide infrastructure that supports investigator collaboration, patient access, and scientific excellence. Primary care research networks such as REAP, RIAPAd, and RICAPPS further expand research opportunities beyond traditional hospital settings [10][11][12][13][14].
Monica Bermejo, Advanced Clinical’s Sr. Manager-Clinical Monitoring-Europe notes, “Advanced Clinical Spain’s research infrastructure continues to evolve through accredited health research institutes, specialised clinical trial units, research support offices, and growing capabilities in early-phase and advanced therapy studies.” According to recent European analyses, Spain has become Europe’s leading country for clinical trial starts and continues to attract increasing investment in clinical research due to the quality of its healthcare system, effective implementation of European regulations, and strong stakeholder coordination [4][15].
Since establishing its European operations in 2019, Advanced Clinical has steadily expanded its presence in Spain, growing from an initial local footprint into a multidisciplinary team supporting Clinical Operations, Global Site Start-Up (GSSU), Functional Service Provider (FSP) partnerships, Safety, Data Management, and other key functions.
Dr Cristobal Perez, Senior Project Manager at Advanced Clinical observed, “The Spain-based team combines deep knowledge of local regulations with strong relationships across investigator sites and healthcare institutions. This local expertise enables us to help sponsors navigate operational complexities while maintaining alignment with global development objectives.”
Importantly, the team serves as a bridge between North American sponsor expectations and European clinical research realities. Through local insight, operational agility, efficient site engagement, and effective communication with investigators and regulatory stakeholders, Advanced Clinical helps sponsors maximise the advantages offered by Spain’s highly developed clinical research environment.
Today, our Spain-based professionals contribute not only to studies conducted locally, but also to programmes delivered across the wider European Union, the United Kingdom, and Australia, reflecting the growing international role of our organisation.
The outlook for clinical research in Spain remains highly positive. Continued growth in advanced therapies, precision medicine, and rare disease research is expected to drive further investment and sponsor interest [2][9].
At the same time, Spain is actively embracing innovation through digital technologies, decentralised trial approaches, and initiatives designed to accelerate study start-up and execution. Ongoing efforts by AEMPS to expand fast-track evaluation pathways further demonstrate the country’s commitment to maintaining competitiveness [1].
There are still challenges. The introduction of CTIS has harmonised regulatory processes across Europe, potentially reducing some of the historical advantages Spain has enjoyed in study start-up timelines. Competition among European countries for the same studies and patient populations is likely to increase [8].
Nevertheless, Spain’s large and increasingly diverse population continues to support strong recruitment performance. While competition among studies may create pressures at high-performing sites, effective site engagement, pre-screening strategies, and experienced local teams can help mitigate these challenges. Language considerations involving Catalan, Basque, or Galician occasionally arise but are generally manageable within multinational trial frameworks.
Spain’s position as a leading clinical research destination is the result of decades of investment in healthcare, education, regulation, and collaboration. Although the European clinical research landscape is becoming increasingly harmonised, Spain continues to distinguish itself through recruitment performance, regulatory maturity, operational quality, and a deeply collaborative research culture.
For sponsors seeking to maximise these advantages, experienced partners with strong local expertise are essential. Through its growing presence and established delivery teams in Spain, Advanced Clinical is well positioned to help organisations successfully navigate and leverage one of Europe’s most dynamic clinical research environments.