Spanish CRO for Clinical Trials in Spain

Patricio Ledesma

Head Of Clinical Operations at Sofpromed

23 November, 2022

Spanish CRO for Clinical Trials in Spain

If you are looking for a CRO to conduct a clinical trial in Spain, please contact us through this link

Spain is a very strategic country for conducting clinical trials. A large number of clinical trial sponsors —not only from Spain but from all over the world, including the United States, Europe and Asia— decide to develop their clinical studies in Spanish hospitals due to the multiple advantages they offer.

In this article, we will explain the main benefits of implementing clinical trials in Spain, including how Sofpromed —a Spanish CRO— can help carry out these studies from beginning to end.

In this article you will learn about:

The Background and Potential of Spain in Clinical Research

Spain is a European country —located in southern Europe— with a long tradition and proven track record in the field of clinical research.

According to the American clinical trials database clinicaltrials.gov, by the end of 2022, a total of 18,085 clinical trials have been conducted in Spain (3,511 of them actively recruiting or pending to start recruiting soon).

These data place Spain among the 4 most active countries in Europe in the development of clinical studies, together with France (7,423 active studies), Germany (3,414), and Italy (3,363). The United Kingdom is at a similar level (3,578).

Spain continues to consolidate its position as one of the world leaders in clinical research. The Spanish Clinical Trials Registry (REEC, by its Spanish initials), which is coordinated by the Spanish Agency for Medicines and Health Products (AEMPS), ended 2021 with close to a thousand new clinical trials underway, a number similar to the all-time record of 2020 and already with an attenuated impact of the coronavirus pandemic.

Spain has become one of the European countries with the best conditions for the development of clinical trials. This is due, among other factors, to the high scientific level of healthcare professionals, the excellence of hospitals, the growing involvement of patients and the confidence of pharmaceutical companies in Spain.

Around 80% of the studies are promoted by pharmaceutical companies, and for many of them Spain is the second best country to conduct them, only behind the United States. [1]

Spain’s Population: 47 Million Inhabitants

When considering Spain as a destination country to carry out a clinical trial, it is useful to look at the size of its population.

The total number of inhabitants registered in official registries in Spain on 1st January 2022 was 47,435,597. This figure represents an increase of 50,490 persons (+0.1%) compared to the data as of 1stJanuary 2021. [2]

In this way, Spain is one of the four most populous countries in Europe, only behind Germany (83 million), France (65 million), and Italy (60 million). The UK has a population of approximately 67 million.

The population of a country is important when planning the recruitment feasibility of a clinical trial. This is especially important when it comes to a clinical study recruiting rare diseases.

Therefore, biotech and pharmaceutical companies planning to conduct clinical trials in Europe should always keep Spain in mind as a highly populated country that can provide a large number of patients for the studies.

The High Quality of the Spanish Healthcare System

Another factor that makes Spain an attractive country for conducting clinical trials is the high quality of its healthcare system.

The Spanish healthcare system is a mixed system in which the National Health System (SNS, in Spanish), which is managed by the public authorities, coexists with an extensive private hospital network.

Nearly 90% of the Spanish inhabitats are covered by the SNS, while 15% have private health insurance. Thanks to this network, universal care in Spain reaches almost 99% of the population. [3]

The SNS has a great decentralization of management. The system has three levels, the first being the Ministry of Health, followed by the organization of the Autonomous Communities, which is in turn divided into health areas.

In short, the Spanish health system has been ranked among the ten best health systems in the world [4], which is a great guarantee when it comes to conducting clinical studies with high quality standards.

Spanish Hospitals with the Highest Number of Clinical Trials

Spain has more than 700 hospitals, with the number of private hospitals being slightly higher than that of public hospitals. These centers have approximately 158,000 beds available, and employ more than 48,000 healthcare professionals and 141,000 service provider workers. [5]

Spain also has many large hospitals that have a high potential to recruit patients with different types of diseases, especially in the provinces of Madrid, Catalonia, Galicia and Andalusia.

The following is a list of the largest hospitales in Spain [6]:

  1. Gregorio Marañón University General Hospital, Madrid (1,671 beds)
  2. Virgen del Rocío University Hospital, Sevilla (1,521 beds)
  3. University Hospital Complex of Santiago, Santiago de Compostela (1,374 beds)
  4. University Hospital Complex of Coruña, La Coruña (1,346 beds)
  5. La Paz University Hospital, Madrid (1,308 beds)
  6. Miguel Servet University Hospital, Zaragoza (1,290 beds)
  7. 12 de Octubre University Hospital, Madrid (1,287 beds)
  8. University Hospital Complex of Vigo, Vigo (1,272 beds)
  9. Vall d’Hebron University Hospital, Barcelona (1,251 beds)
  10. Reina Sofía University Hospital, Córdoba (1,233 beds)

Regarding the number of clinical trials conducted, special mention should be made of the Vall d’Hebron University Hospital in Barcelona, which is one of the leading centers for clinical studies in Spain.

In 2021, Vall d’Hebron reached a record of 1,580 active clinical trials and 443 new clinical trials, including those carried out by the Vall d’Hebron Research Institute (744) and the Vall d’Hebron Institute of Oncology (836). A total of 2,873 patients participated in these trials. These figures exceed the 2020 mark, which, despite the pandemic, closed with 1,365 active clinical trials and 319 new ones, which already represented the highest figures ever recorded. [7]

The Rapid Start-up of Clinical Trials in Spain

Another favorable aspect for the execution of clinical trials in Spain is the time required to obtain regulatory agency and ethics committee approvals.

In Spain, a clinical trial —even a multicenter one— requires two authorizations: (1) the approval of the Spanish Agency of Medicines and Medical Devices (AEMPS), and (2) the favorable opinion of the Ethics Committee of Research with Medicines (CEIm).

If a sponsor has the main documents ready to submit the application for study approval to the AEMPS and the CEIm, the time needed to obtain both approvals is around 60-90 days, depending on the number and complexity of the clarifications requested by these bodies.

Moreover, the negotiation of contracts with hospitals can be initiated in parallel to the application for trial approval. This means that site contracts can be ready to be signed as soon as the necessary regulatory and ethical approvals are received.

In brief, a clinical trial can be activated in Spain in about 3 months from the beginning of the start-up process, also taking into account the time needed to complete the start-up visits at the participating hospitals.

An Ideal CRO for Clinical Trials in Spain

Sponsors wishing to conduct clinical trials in Spain can contract Spanish clinical research organisations (CROs) specialized in the full management of clinical studies.

Sofpromed is a CRO located in Spain, specifically in the city of Palma de Mallorca, specialized in the management of clinical trials from beginning to end.

Biotechnology and pharmaceutical companies can delegate to Sofpromed all the management tasks required in a clinical trial, including start-up, regulatory and ethical approvals, contract management, start-up visits, monitoring, data management, pharmacovigilance, and overall project management, among others.

Sofpromed can manage clinical trials in different therapeutic areas, especially in oncology, vascular, metabolic and central nervous system diseases, as well as dermatology, and infectious and respiratory diseases.

Conclusion

Spain is a highly recommended country for conducting clinical trials. Its long history in clinical research, its large population, the high quality of its healthcare system, the recruitment potential of its hospitals, and the short start-up times make Spain a leading country for carrying out clinical studies in any therapeutic area. Clinical trial sponsors will undoubtedly be right to consider Spain for their next study in Europe.

If you are looking for a CRO to conduct a clinical trial in Spain, please contact us through this link

Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266  pledesma@sofpromed.com 

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Patricio Ledesma

Patricio Ledesma (B.Eng Concordia University, Montreal, Canada and Master’s Degree in Clinical Trials, University of Seville, Spain) is the Head of Clinical Operations and Founder at Sofpromed CRO. Patricio is a professional consultant providing comprehensive, one-stop expert advice and guidance to biotechnology and pharmaceutical companies worldwide in the field of clinical trials and drug development. He is personally and enthusiastically devoted to helping biotech Chief Executive, Operations, Scientific, Medical, and Regulatory Officers in the planning and execution of phase I-IV clinical trials across North America, Europe, Asia-Pacific, Latin America, and Middle East regions. You can contact Patricio at: +34 607 939 266 pledesma@sofpromed.com