- David Jones
- Nov 15
- 10 min read
CROs in Spain & Portugal
Spain and Portugal offer an exceptional environment for clinical research, underpinned by advanced healthcare systems and well-integrated medical infrastructure across the Iberian Peninsula's diverse regions. The combined population of approximately 58 million represents one of Europe's most significant and well-documented patient pools, with comprehensive healthcare coverage through their respective national systems and established clinical trial participation networks across major metropolitan areas and regional centres.
Both countries benefit from streamlined regulatory processes through the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) and INFARMED, alongside prestigious academic institutions, university hospitals, and specialised research centres. A key advantage is the Iberian region's sophisticated health data infrastructure and established research networks, including Spain's extensive Red Nacional de Investigación en Terapias Avanzadas and Portugal's collaborative clinical research platforms, which facilitate efficient patient recruitment and comprehensive trial monitoring across therapeutic areas.
The Spanish and Portuguese CRO landscape features a mix of specialized boutique organizations and comprehensive full-service providers, offering sponsors access to high-quality data collection and strong patient retention rates. These CROs have developed particular expertise in leveraging the region's advantages, including competitive operational costs, multilingual capabilities, and strong connections to both European and Latin American research networks, to conduct Phase I-IV clinical trials effectively.
Iberian CROs excel at managing multinational trials, benefiting from the region's strategic position bridging Europe, Latin America, and North Africa, and its growing prominence in European medical research. They offer expertise in navigating both national and EU-wide regulatory requirements, while maintaining strong connections with key opinion leaders and research institutions across the countries' renowned academic medical centres.
COG: CRO Summit Europe brings together leaders from Contract Research Organizations and functional service providers to explore cutting-edge strategies in clinical trial delivery, operational excellence, and industry innovation.
This premier two-day gathering in Amsterdam delivers actionable insights on emerging technologies, site relationships, and the future of the European CRO landscape.
Find Our More Here: https://www.thepbcgroup.com/cog-cro-summit-europe
Here you can find a selection of emerging, medium, and large full-service France-based clinical research organizations (CROs) conducting and managing Phase I-IV clinical trials, each bringing unique expertise in navigating the region's healthcare systems and regulatory requirements.
León Research
León Research is a leading Spain-based CRO with headquarters in León and offices in Madrid, Barcelona, and Coimbra (Portugal). They provide comprehensive clinical development services including clinical trial management, regulatory affairs, data management, and pharmacovigilance across Phase I-IV trials. Founded in 2007, they specialize in ophthalmology studies, observational research, and food supplement trials, serving pharmaceutical, biotech, and medical device companies throughout Europe with particular expertise in the Spanish and Portuguese markets.
Sofpromed
Sofpromed is a Barcelona-based full-service CRO specializing in the global management of Phase I-IV clinical trials for pharmaceutical and biotechnology companies. They provide end-to-end clinical development services including regulatory affairs, site management, clinical monitoring, data management, biostatistics, and medical writing. With extensive experience conducting trials throughout Spain's major cities including Madrid, Barcelona, Valencia, and Seville, Sofpromed combines local market expertise with international capabilities, offering cost-effective alternatives to larger multinational CROs while maintaining high-quality standards across all therapeutic areas.
BioClever
BioClever is a full-service CRO with offices in Barcelona and Madrid, providing comprehensive clinical research support throughout Spain. They offer a complete range of services including clinical trial design and management, observational studies, nutritional research for food supplements, data management, and regulatory affairs. With years of experience in the pharmaceutical and food industries, BioClever combines the personalized attention and flexibility of a mid-sized organization with professional expertise across all phases of clinical development, delivering quality-focused solutions to sponsors seeking efficient trial execution in the Spanish market.
Sermes CRO
Sermes CRO is a Barcelona-based full-service clinical research organization with additional operations in Madrid, specializing in clinical trial management and regulatory expertise. They provide comprehensive services including clinical operations, monitoring, data management, regulatory affairs, and quality assurance across Phase I-IV trials. With notable expertise in the EU Clinical Trials Information System (CTIS) and advanced therapy medicinal products, Sermes serves pharmaceutical, biotech, and academic sponsors seeking strategic scientific advice and support for conducting clinical research in Spain and across Europe.
Advanced Clinical
Advanced Clinical is a European CRO with significant operations in Spain and Portugal, providing full-service clinical development solutions across the Iberian Peninsula. They offer comprehensive services including clinical trial management, site monitoring, regulatory affairs, data management, and pharmacovigilance for Phase I-IV studies. With offices strategically located in Madrid and other key Iberian cities, Advanced Clinical combines local market knowledge with European-wide capabilities, serving pharmaceutical and biotechnology companies conducting clinical research in Spain and Portugal across multiple therapeutic areas including oncology, cardiovascular, and metabolic diseases.
Avania
Avania is a mid-sized Global CRO with a strong presence in Spain following its acquisition of Barcelona-based Anagram CRO. They provide full-service clinical development solutions including clinical operations, regulatory affairs, data management, medical writing, and quality assurance across Phase I-IV trials. With offices in Barcelona and Madrid, Avania combines regional expertise in the Spanish market with broader European capabilities, serving pharmaceutical, biotechnology, and medical device companies. Their integrated approach and therapeutic area expertise make them a strategic partner for sponsors conducting clinical research throughout Spain and the wider European market.
Pivotal CRO
Pivotal is a Madrid-based specialized CRO founded in 2001, offering full-service clinical development with a strong focus on oncology and innovative therapies. They provide comprehensive services including clinical trial design, international networking, regulatory strategy, data management, and scientific publications across all trial phases. With over 50 employees and extensive experience in solid tumors including prostate, lung, breast, ovarian, and endometrial cancers, Pivotal delivers strategic scientific and medical advice as the backbone of clinical trials, combining therapeutic expertise with a patient-centric approach to support pharmaceutical and biotechnology companies developing novel cancer treatments.
APICES
APICES is a Madrid-based CRO founded in the late 1990s by highly qualified professionals with extensive experience in contract research organizations and pharmaceutical companies. They provide clinical research services with a Spanish identity and international vocation, supporting clinical trial management and pharmaceutical development across Europe. With their headquarters in San Sebastián de los Reyes, Madrid, APICES combines local market expertise with a commitment to quality and professionalism, serving pharmaceutical and biotechnology sponsors seeking reliable clinical research support in Spain and broader European markets across multiple therapeutic areas.
Aixial Group
Aixial Group isn't your typical CRO. With over 30 years of experience navigating the complex landscape of global clinical trials, Aixial combines deep therapeutic expertise with an agile, technology-driven approach to deliver smarter, faster, and more efficient clinical studies across all phases. Their operations span continents, leveraging strong local presence and culturally attuned teams to transform global trials into highly responsive, seamlessly coordinated operations. Specializing in complex therapeutic areas including rare diseases, oncology, and neurology, Aixial offers flexible solutions—from full-service support to functional services or hybrid approaches—tailored to meet clients exactly where they are in their clinical journey. More than trial managers, they are committed partners in advancing medicine, with every study supported being a step toward better treatments and outcomes for patients worldwide.
OPIS
OPIS is an Italian-founded CRO established in 1998 with significant operations in Spain and Portugal, providing full-service clinical development solutions across the Iberian Peninsula. They offer comprehensive services including clinical trial management, regulatory affairs, monitoring, data management, and pharmacovigilance for Phase I-IV studies. With offices in Barcelona and Madrid, OPIS has expanded its European footprint over more than 20 years through dedicated client partnerships and scientific community engagement, serving pharmaceutical and biotechnology companies conducting clinical research in Spain and Portugal with a commitment to quality and therapeutic expertise across multiple disease areas.
Evidenze
Evidenze is a Madrid and Barcelona-based full-service CRO founded in 2004 (formerly known as Dynamic Solutions), providing comprehensive clinical research services across Phase I-IV trials. They offer an integrated approach combining clinical research, medical education, digital health, patient support, scientific events, and data services to support the entire drug lifecycle. With offices in Alcobendas (Madrid) and Barcelona, Evidenze positions itself as a "Full Value CRO" with a multidisciplinary internal structure, delivering differential solutions through specialized units including regulatory affairs, quality assurance, project management, and scientific communication to pharmaceutical, biotechnology, and healthcare clients throughout Spain and internationally.
Cabyc Research
Cabyc Research is a Madrid-based CRO founded in 1998, providing clinical research services throughout Spain with headquarters in San Sebastián de los Reyes. They offer comprehensive clinical trial management services including regulatory affairs, monitoring, data management, and project coordination across multiple therapeutic areas. With over 25 years of experience in the Spanish clinical research market, Cabyc combines local expertise with established relationships at Spanish clinical sites, serving pharmaceutical and biotechnology companies seeking reliable clinical trial execution. Their mid-sized structure allows for personalized attention while maintaining the professional standards required for conducting Phase I-IV clinical studies in Spain's key research centers.
Linical
Linical is a Japanese-founded CRO established in 2005 by professionals with extensive pharmaceutical company experience. They provide clinical research services in Spain as part of Linical's international network, offering clinical trial management and support across various phases of drug development. With their unique Japanese-European business model, Linical Spain combines international quality standards with local Spanish market knowledge, serving both Asian pharmaceutical companies entering European markets and Western clients seeking experienced CRO support. Their presence in Spain enables efficient coordination of clinical trials while maintaining the rigorous operational excellence characteristic of Japanese pharmaceutical research standards.
CETERA
CETERA is a Lisbon-based clinical research organization providing comprehensive CRO services throughout Portugal, specializing in full regulatory submissions and clinical trial management. They offer end-to-end services including feasibility assessments, site selection and identification, investigator contract negotiation, clinical monitoring, project management, medical monitoring, scientific consultancy, translation, medical writing, and regulatory affairs. With expertise in navigating Portuguese regulatory requirements and ethics committee processes, CETERA serves pharmaceutical, biotechnology, and medical device companies seeking to conduct clinical trials in Portugal. Their integrated service model ensures seamless coordination from study planning through completion, supporting both local and international sponsors in the Portuguese clinical research landscape.
NOVA Clinical Research Unit
NOVA Clinical Research Unit (NOVA CRU) is a Lisbon-based academic clinical research organization established as a joint venture between NOVA Medical School (NMS) and NOVA Information Management School (NOVA-IMS) from Universidade NOVA de Lisboa. They provide expertise and support for designing and managing multicenter randomized controlled trials and other complex clinical studies at non-for-profit rates, adhering to standards required by ethics and regulatory authorities. As an academic CTU/CRO, NOVA CRU combines medical expertise with advanced data management and statistical capabilities, serving investigator-initiated research and academic-led clinical trials throughout Portugal. Their university affiliation ensures rigorous scientific methodology while offering cost-effective solutions for researchers and sponsors conducting high-quality clinical research in the Portuguese healthcare system.
IQVIA
IQVIA is a global healthcare intelligence leader with significant operations in Spain and Portugal, maintaining offices in Barcelona, Madrid, and Lisbon. As the world's largest CRO, they provide comprehensive clinical development services including protocol design, Phase I-IV trial management, site identification, patient recruitment, real-world evidence, and advanced analytics across all therapeutic areas. In the Iberian Peninsula, IQVIA has been operating for 50 years in Portugal (since 1974) and maintains extensive presence in Spain, combining their global data resources and technological capabilities with deep local market knowledge. Their Iberian operations serve pharmaceutical, biotechnology, and medical device companies with integrated solutions that leverage healthcare data, advanced analytics, and clinical research expertise to accelerate drug development throughout Spain and Portugal.
ICON
ICON is a global full-service CRO headquartered in Dublin, Ireland, with substantial operations in Spain through offices in Barcelona and Madrid, as well as remote opportunities across the country. They provide comprehensive outsourced development and commercialization services including Phase I-IV clinical trial management, data management, laboratory support, and strategic consulting across all therapeutic areas. With a network spanning 45 countries and over 90 offices globally, ICON's Spanish operations benefit from deep local expertise combined with international resources, serving pharmaceutical, biotechnology, and medical device companies. Recognized with multiple CRO Leadership Awards, ICON's presence in Spain positions them as a key partner for conducting clinical research in one of Europe's most active clinical trial markets.
Medpace
Medpace is a global full-service CRO with operations in Spain as part of its extensive European footprint spanning 21 countries across the continent. They provide therapeutically-focused clinical development services with specialized expertise in areas such as oncology, cardiology, metabolic diseases, and central nervous system disorders across Phase I-IV trials. With offices strategically located throughout Europe including Spain, Medpace expanded significantly in recent years, adding clinical research professionals and facilities to support the region's growing pharmaceutical development needs. Their unique global partnering philosophy emphasizes an uncompromising commitment to clinical research excellence and ethical standards, serving pharmaceutical and biotechnology clients with comprehensive services including clinical operations, biostatistics, data management, regulatory affairs, and quality assurance throughout the Spanish market.
Medsir
MEDSIR (Medica Scientia Innovation Research) is a Barcelona-based oncology-focused clinical research organization founded in 2012 by scientific experts, specializing in the design and strategic management of innovative cancer clinical trials. They provide comprehensive services from study conception through publication, supporting clinical investigators, pharmaceutical companies, and patients with a collaborative research model across breast, lung, thymic, and other solid tumor cancers. With over 120 dedicated staff, presence in more than 14 countries including Spain, and having developed over 65 trials involving more than 2,600 patients across 196 sites, MEDSIR combines high-level clinical expertise with strategic development services. Their patient-centric approach includes scientific support, trial design, and the Convive con el Cáncer patient portal, positioning them as a leading oncology CRO in Spain and internationally.
Effice CRO
Effice is a Madrid-based CRO with over 19 years of experience providing quality clinical research services throughout Spain, specializing in comprehensive clinical trial management for pharmaceutical, biotechnology, and independent research organizations. They offer full-service capabilities including clinical study design, project management, monitoring, biostatistics, pharmacovigilance, and data management with highly qualified personnel across all therapeutic areas. Located on Paseo de la Castellana in Madrid, Effice focuses on delivering personalized, flexible solutions that adapt to client budgets and resources while maintaining rigorous quality standards and regulatory compliance. Their commitment to patient safety, data integrity, and transparent client communication positions them as a trusted partner for both commercial sponsors and independent investigators conducting high-quality clinical studies in Spain.
Caidya
Caidya is a global full-service CRO with operations in Spain through its Madrid office located on Calle de María de Molina. Formed in 2021 through the merger of Clinipace and dMed Global, Caidya provides comprehensive clinical development services including early phase development, Phase II/III studies, regulatory affairs, pharmacovigilance, data management, and biostatistics across all therapeutic areas. With nearly 1,800 employees operating in over 30 countries worldwide, Caidya combines global reach with local expertise in Spain and Portugal, offering flexible, patient-centric trial solutions. Their therapeutic expertise spans oncology, rare diseases, dermatology, cardiology, and cell and gene therapy, serving pharmaceutical and biotechnology companies with personalized clinical research support throughout the Iberian Peninsula and broader European markets.
Allucent
Allucent is a global full-service CRO with European operations including offices in Madrid, Spain, as well as Amsterdam (Netherlands), and across multiple European countries. Formed through the convergence of several leading providers including Pharm-Olam, Allucent specializes in supporting small and mid-sized biotechnology companies through complex drug development challenges from early-stage to post-approval. With over 30 years of combined experience conducting trials in more than 70 countries, Allucent provides comprehensive services including clinical development, clinical pharmacology, regulatory strategy, and pharmacovigilance with particular expertise in oncology, neuroscience, and infectious diseases. Their Madrid office contributes to Allucent's strong European presence, offering personalized partnership approaches and operational excellence to sponsors conducting clinical research throughout Spain, Portugal, and broader European markets.
COG: CRO Summit Europe brings together leaders from Contract Research Organizations and functional service providers to explore cutting-edge strategies in clinical trial delivery, operational excellence, and industry innovation.
This premier two-day gathering in Amsterdam delivers actionable insights on emerging technologies, site relationships, and the future of the European CRO landscape.
Find Our More Here: https://www.thepbcgroup.com/cog-cro-summit-europe
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