Western Europe

Clinical trial services and Consulting in Western Europe.

Europe offers great opportunities for conducting high quality clinical research due to the existing centralized healthcare infrastructure, well-trained researchers and the generally high level of interest in the field of clinical research both the investigator and patient sides.

70% of clinical studies fail due to poor selection of clinical investigators and sites. Meditrial has an extensive database of sites and a broad network of clinical investigators in Europe and worldwide. Thanks to that, we can fulfil your clinical study requirements and recruit for you the most qualified clinical investigators and relevant sites for your research.

Moreover, we offer comprehensive clinical trial monitoring and site management services to support clinical trials around the world. We ensure that the study is conducted according to the protocol, GCP, SOP, and international regulatory requirements.

Our expertise covers all areas of Europe: Western, Eastern and Southern Europe. Meditrial can efficiently manage your studies thanks to our experts in local regulations and languages.

France

Approval Process

Regulations concerning the review and approval of clinical research studies are published on the website of the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). The French regulations integrate the transposition of the European Directive on Medicinal Products 2001/20/EC and on Medical Devices 93/42/EEC.

Clinical trial start-up time: 3.5 months

Italy

Approval Process

In Italy, the conduct of clinical trials is subject to authorization by the Competent Authority Agenzia Italiana del Farmaco – AIFA and positive opinion by the Ethics Committee. The applicable regulation for clinical trial conduct is the Legislative Decree 24 June 2003, No. 211 transposing Directive 2001/20/EC concerning the implementation of GCP.

Clinical trial start-up time: 5 – 5.5 months

Germany

Approval Process

The approval process is following the EU legislation (clinical trial directive 2001/20 EC), including the German Medicinal Drug Law. Clinical trials in Germany have to be approved by the respective competent federal higher authority, either the BfArM or the PEI depending on the type of product.
Clinical trial start-up time: 4 months

Investigators and Sites

Germany hosts around 2,000 hospitals and 340,000 physicians of whom two-thirds are specialists, and provides one of the highest standards of treatment and diagnostic procedures. Hospitals and clinics are usually very well organized and so to fulfill the strictest national requirements of clinical research.

Spain

Approval Process

Clinical trials in Spain are regulated in accordance with the Royal Decree 1090/2015, and the Regulation (UE) No 536/2014 of the European Parliament and of the Council. The initiation of a clinical trial in Spain requires two key approvals: by an authorized Ethics Committee and by the national regulatory authority, the Spanish Agency of Medicines and Medical Devices (AEMPS).
Clinical trial start-up time: 5 – 6 months

Investigators and sites

Spain a key player in research and development at the European and global levels and an innovation and knowledge hub with research centers of excellence. Over the past few years, Spain has been specializing in clinical research so that nowadays many hospitals own a research unit for clinical trials to ensure high- quality research both in terms of data and patients’ safety.

Portugal

Approval process

The conduct of clinical trials in Portugal requires the prior authorization of INFARMED, IP, and favorable opinion of the National Ethics Committee for Clinical Research (CEIC). Clinical research in Portugal is regulated by the Law 21/2014 of 16 April covering all clinical research with humans including medicinal products, medical devices, cosmetics, food supplements, and all kinds of observational studies.
Clinical trial start-up time: 2 – 3 months

Investigators and sites

Portugal hosts many universities and central hospitals mostly located in major cities such as Lisbon, Porto, and Coimbra, with experienced staff to assist in the studies. Investigators are usually well experienced in conducting clinical research, and also an excellent command of English. Recruitment rates are generally high thanks to the close follow-up from the very time the protocol is submitted for approval. Patient compliance is good. Portugal has witnessed a significant increase both in the number of industry-sponsored trials and academic studies.

Danemark

Approval process

Denmark has one of the fastest approval systems in Europe for clinical trial authorization. Applications should be submitted to the Danish Medicines Agency, which handles them is 30 days. Moreover, trials must also be notified to a research ethics committee, which performs an overall assessment of the trial’s ethical aspects. Approvals must be obtained from both a research ethics committee and the Danish Medicines Agency.

Recruitment potential

Denmark set up registry reporting on patients and their specific disease codes and current/past medication. That makes very simple researching and recruiting patients. Moreover, Danish citizens are usually open to participation in clinical trials. As a matter of facts, about 20,000 Danes volunteer as participants in clinical trials each year.

Belgium

Approval process

The application for clinical research authorization should be submitted to the competent authority FAMHP depending on the type of study – medical device research, interventional / observational, pre-market / post market. In addition, all studies must be approved by an accredited Ethics Committee. Both applications can be submitted in parallel. Regarding investigations with a medical device, the FAMHP may approve the study only after the EC grants its authorization.
Clinical trial start-up time: 2-3 months

Netherlands

Approval process

Clinical studies on medicinal products must be approved by a certified ethics committee. Whenever clinical studies involve specialised medicinal products such as nucleotides or stem cells they must also be approved by the Dutch competent authority. Usually, approval is granted within four weeks of submitting the application.
Clinical trial start-up time: 2-3 months

Sweden

Approval Process

In order to conduct a clinical study in Sweden, an application should be submitted and have the research ethically reviewed and approved by the Ethical Review Authority. The time for the Ethical Review Authority to review applications is about 60 days. Before starting, all studies must be registered in a publicly accessible database.