Subject to a successful audit, clinical trial units (CTUs) may be designated as Certified ECRIN Data Centres. Audits are based on standard requirements developed by ECRIN in three areas: IT, data management and general. Certified centres are invited to sign a collaborative agreement with ECRIN. Learn more
The following centres have received ECRIN Data Certification:
The AIBILI Data Centre is a structure to support investigator-initiated research providing data management and electronic data capture solutions. The services performed by AIBILI Data Centre include:
AIBILI Data Centre has been certified since 2016.
UPCET is a platform for research and clinical trials, founded in 1972. It offers innovative and quality services including optimization of therapeutic development by modeling; transactional research studies; eCRF studies; multicentre studies; international studies; evaluation studies of medical technologies and observational studies. In addition, it provides study coordination, data management, methodological support; and optimisation of development.
The Clinical Trials Unit Freiburg is a central facility of the University of Freiburg’s Faculty of Medicine and the Medical Center – University of Freiburg. Founded in 1997 (under its former name, Center for Clinical Studies), the Clinical Trials Unit contributes to compliance with international quality standards. It participates in a number of international joint research projects and provides support to clinical researchers in applying for, planning, conducting, and publishing their patient-centered scientific projects.
Initially certified from 2015-2019.
Information to be provided.
Dept. of Research Support for Clinical Trials (CTU) provides advising, training courses and operational support for academic research at all hospitals in the South East Health region of Norway. The CTU in its current form was established 1 September 2017 and today has a competent team of 32 staff. The CTU covers a broad academic and professional range, and contributes with expertise in GCP and quality assurance, statistics, monitoring, data management, health economics, patient-reported outcomes and user participation in research. Our multidisciplinary teams ensure good quality in planning, conducting and reporting of studies.
EUropean CLInical trials & Development (EUCLID) is an academic platform for clinical trial services. It brings together expertise in biomedical research from university hospitals/structures and the French National Institute of Health and Medical Research (INSERM) in Bordeaux and Limoges. The mission of EUCLID is to develop methodological innovations and tailored solutions to optimally design clinical trials, develop protocols, obtain funding, seek ethical and regulatory approval, manage trial logistics, sub contract services for drug management or imaging studies, ensure vigilance and safety procedure, perform data management, conduct statistical analyses and write scientific reports and articles.
The Italian Group for Haematological Diseases in Adults (GIMEMA) began with a small group of Italian hematology centers in 1982 that teamed up to compare studies to achieve greater results. Since its inception, the group has established a network of almost all hematology centres in Italy, which, between them, treat all hematological diseases. Now, GIMEMA is recognized as a non-profit foundation which promotes its activities through its various bodies. Clinical research projects are managed by the GIMEMA Data Center which ensures they adhere to all regulations. The centralised diagnosis capabilities of the group allow all GIMEMA treatment centers to offer patients the same exceptional level of diagnosis and treatment.
IZKS (Interdisciplinary Centre for Clinical Trials) is a professional academic clinical trial organisation at the University Medical Centre (UMC) Mainz. IZKS connects clinical trial activities in clinical trial units with non-clinical and methodological study activities. Success and achievements have been judged as very good in several evaluations reflecting high level of quality and efficiency of tasks taken over in clinical trials by IZKS.
KKS Dresden – Coordination Centre for Clinical Trials Dresden is part of the Faculty of Medicine Carl Gustav Carus of the Technische Universität Dresden.
The Faculty of Medicine Carl Gustav Carus supports its researchers by providing a wide variety of services, which extend from assisting in the search for suitable funding programmes and the preparation of applications, to the successful completion of projects.
The Coordination Centre for Clinical Studies (KKS) is a central element of the Faculty of Medicine at Düsseldorf’s Heinrich Heine University. The KKS supports clinical, primarily multi-centre studies taking into consideration Good Clinical Practice (GCP) and academic criteria, relating to both admission-relevant studies and exclusively academically focused studies. Furthermore, the KKS’ staff train tutors and offer further training courses (for example for academic assistants, monitors or clinical researchers in rotation). They organise and hold further training events on the subject of clinical studies, In addition, the KKS provides methodological know-how on request. Within the context of its activities, the KKS also processes genuinely academic issues.
The Coordination Centre for Clinical Trials (KKS) Heidelberg, Germany is directly located at the Medical Faculty and the University Hospital Heidelberg. More than 60 staff members support the whole spectrum of clinical research with a focus on conception, planning, conducting, and analysing innovative clinical studies according to current laws and international guidelines, e.g. Good Clinical Practice (ICH-GCP). The KKS Heidelberg has been working effectively since July 2000 and has been evaluated by different audits, inspections and expert assessments with successful outcome concerning quality and efficiency. KKS Heidelberg is already involved in international innovative phase I to IV studies according to Drug Law and projects following Medical Device Law inclusive in vitro diagnostics and different therapeutic procedures, e.g. in surgery and psychotherapy .
All functions will be performed according to Standard Operating Procedures (SOPs) of KKS Heidelberg which are based on ICH-GCP guidelines, the implementation of GCP and current laws. In order to ensure the quality, the patient protection, compliance with ethical and legal stipulations as well as the application of adequate methods KKS Heidelberg provides e.g. the following services to clinical trials:
The KKS Marburg is an independent facility of the Medical Faculty of the Philipps-University Marburg which supports clinical trials on oncology, internal medicine, cardiology, surgery, neurology and other indications.
In recent years, the KKS Marburg has established several subject-specific modules in cooperation with other institutes of the University of Marburg. The KKS Marburg also cooperates with well-known study groups, such as the study group on gynecological oncology (German abb.: AGO), German Parkinson Study group (GPS) or the European Network for the Study of Adrenal Tumours (ENS@T).
The KKS Marburg supports physicians and scientists in all areas of the planning, implementation and analysis of clinical trials.
For clinical trials in humans initiated by scientists at the Philipps-University Marburg (IITs), the University of Marburg acquires the sponsor responsibility in the sense of §4 (24) Arzneimittelgesetz (AMG, German drug law) and §3 (23) Medizinproduktegesetz (MPG, Medical Devices Act). As the sponsor responsibility is delegated by the president of the university to the KKS Marburg, the KKS represents the University Marburg as sponsor in the relation to third parties.
The KKS Marburg regularly publishes the results of clinical trials in scientific journals and at international congresses together with the principal investigator.
For a good cooperation with you, we assume that the planned project has medical and scientific relevance and that compliance with ethical principles, legal regulations and international ICH-GCP standards is also self-evident to you.
Bambino Gesù is the largest paediatric hospital and research center in Europe, with connections to leading international centers in the sector. The hospital has a staff of almost 3,300 including physicians, researchers, nurses, clinical technicians and office staff.
The hospital treats and cares for a large number of patients: over 1.900.000 healthcare services are provided each year to children and adolescents from all over the world. Comparable to a city in its size, the hospital is inhabited by children who are treated, monitored and supported within an affordable, comprehensive and high-quality healthcare solution.
As Sweden's largest clinical research centre, the Uppsala Clinical Research Center (UCR) combine academic excellence with clinical expertise in an innovative research infrastructure. Its services include all aspects of clinical studies, biobanks, lab analyses and quality monitoring in health and healthcare.
The ZKS Leipzig is a core facility of the Medical Faculty of the University Leipzig and was established in 1999 with funding from the Federal Ministry of Education and Research (BMBF). ZKS Leipzig is a full service academic contract research organisation (CRO), mainly for support of all stages of investigator-initiated trials (IITs), e.g. study design and protocol development; project management/regulatory issues; data management/databases including eCRF; risk-based monitoring including on-site clinical monitoring and central monitoring; safety management and reporting for medicinal product and medical device trials; statistical analysis, reports and publication.
ZKS Leipzig offers a broad spectrum of advanced training programmes in patient-oriented clinical research. Furthermore, the ZKS Leipzig provides support for decentral trial offices in clinics, for example: study set-up, budget calculation, and feasibility.
The Clinical Trial Centre Cologne supports both academic and industrial clinical trials in compliance with GCP, international directives, guidelines and standards. Its service offer includes consulting, trial preparation and conduct support, data management, site management, quality management and more.
In the context of its trial support activities and projects, ECRIN works with multiple partners across Europe. One example is 'ECRIN Nutrition', a network of 80 European nutrition clinical research sites from 21 European countries, which was created through the ECRIN Integrating Activity (ECRIN-IA) project (funded by the European Union’s Seventh Framework Programme for Capacities - Research Infrastructures under grant agreement no. 284395). Learn more
Affiliate and International Partners
ECRIN works with many other partners across the globe. These groups or organisations are typically focused on clinical research in general, or on a specific research area or disease in particular. Located in Europe and internationally, they may be directly involved in ECRIN-supported trials or collaborative projects, or may also simply wish to maintain close contact with ECRIN and support its goals. ECRIN's partners may be designated as affiliate or international partners, depending on the nature of the collaboration and agreement signed (i.e., framework agreement or MoU).
EVICR.net and ECRIN signed a framework agreement in 2015. EVICR.net is a network of European ophthalmological clinical research sites dedicated to performing the highest quality clinical research. Following European and international directives for clinical research and common standard operating procedures (SOPs), EVICR.net aims to strengthen the capacity of the European Union to study the determinants of ophthalmic diseases and to develop and optimise the use of diagnostic, prevention and treatment strategies in ophthalmology. EVICR.net is an independent European Economic Interest Grouping (EEIG) established in 2010 in accordance with the Council Regulation (EEC) n.º 2137/85. EVICR.net is headquartered in Coimbra, Portugal at the Association for Innovation and Biomedical Research on Light and Image (AIBILI), which acts as the organisation’s coordinating centre.
The European Patients’ Academy on Therapeutic Innovation (EUPATI) is a multi-stakeholder public-private partnership originally launched by the IMI-EUPATI project (2012-2017) and hosted by the European Patients’ Forum (EPF) from 2017 to 2020. EUPATI is today established as an independent non-profit Foundation in the Netherlands.
EUPATI provides education and training to increase the capacity and capability of patients and patient representatives to understand and meaningfully contribute to medicines research and development, and to improve the availability of medical information for patients and other stakeholders. In addition, EUPATI provides an open-access multilingual Toolbox, that has served more than 5 million users in 13 languages around the world to date.
Read more about the ECRIN patient engagement here.
FBRI and ECRIN signed an MoU in July 2016. FBRI is a Japanese public interest incorporated foundation, which was established in March 2000. Its basic mission is to contribute to the revitalisation of the economy of Kobe city and the Kansai region and the improvement of health/welfare of citizens and the general public. FBRI also aims to ensure higher health care levels in the world through various activities.
KoNECT and ECRIN signed an MoU in April 2015. KoNECT works to foster Korean clinical trial capabilities and advance infrastructure, training and development of clinical trial professionals and R&D in new technologies. KoNECT’s goals align with ECRIN’s mission to promote high-quality, multinational clinical research. The partnership will increase mutual understanding of regulation and ethical requirements, trial management, and funding in Korea and Europe, leading to collaborative clinical trials. KoNECT is a Korean nonprofit organization funded by the Korean government, committed to achieving the status of a global clinical trial hub and a preferred partner for global drug development, ultimately contributing to earlier access of patients to innovative treatments to be developed either in Korea or outside Korea.
The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) is focused on accelerating the process of turning research findings and observations into treatments and cures for disease. NCATS does this by developing new approaches and technologies, demonstrating their usefulness and disseminating to the community. NCATS is involved in collaborations with government, academia, industry and nonprofit patient organizations, including ECRIN.
Inaugurated on May 25, 1900 under the name of Federal Serotherapy Institute, FIOCRUZ was given the mission of fighting the great public health problems in Brazil. Today, the institution is responsible for a range of activities which include research development; hospital and ambulatory care services; production of vaccines, drugs, reagents, and diagnostic kits; education and training of human resources; information and communication in the area of health, science and technology; quality control of products and services, and the implementation of social programs. It has over 11,000 employees and health professionals.
Therapeutic Innovation Australia Ltd (TIA) and ECRIN signed an MoU in May 2014. The aim of the partnership is to foster international collaboration on clinical trials between Europe and Australia through the development of shared tools (e.g. on regulation, quality, training and monitoring strategies) and through coordinated support to international trials.
TIA is an Australian not-for-profit company that supports translational health researchers in taking medical research from the laboratory to clinical application. TIA’s national network consists of 45 sites located at universities, medical research organisations, hospitals and clinical networks that enable development of small molecules, biopharmaceuticals, cell therapies and biomarkers. TIA facilitates partnerships between researchers, capability managers and experts in product development from academic and industry sectors.
