Data Centres
Certified Data Centres
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.
Discover more on ECRIN data center certification.
The following centres have received ECRIN Data Certification:
Location: Coimbra, Portugal
Certification period: 2021 - 2025
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:
- design and development of electronic case report forms (eCRFs)
- design and development of clinical data management applications (CDMA)
- data entry
- IT support
- eCRF and CDMA training and data management
- long term storage
AIBILI Data Centre has been certified since 2016.
Location: Rennes, France
Certification period: 2023 - 2027
The Clinical d'Investigation Clinique Rennes (CIC Inserm 1414) is a central facility of the University of Rennes 1 and the Rennes University Hospital (CHU). This centre supports physicians at the Rennes University Hospital to undertake clinical research projects, from the development of the protocol (methodology) through to scientific publication, and including the clinical study and data analysis. Both projects addressing gaining a better understanding of a given pathology or testing of treatments or medical devices.
Location: Frieberg, Germany
Certification period: 2022 - 2026
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.
Location: Basel, Switzerland
Certification period: 2020 - 2023
The Department of Clinical Research (DKF) at the University of Basel/University Hospital Basel (USB) is a member of the Swiss Clinical Trial Organisation (SCTO). Established in 2014, they offer consulting and other services for the planning and conduct of clinical trials including data management related services.
Their data management services include training, the development of study protocol and data management plan, the design and implementation of case report forms, database excerpts and study participant randomisation, data preparation and data export.
Location: Oslo, Norway
Certification period: 2019 - 2023
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.
Location: Rome, Italy
Certification period: 2021 - 2026
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.
GIMEMA has been certified since 2015.
Location: Brno, Czech Republic
Certification period: 2024 - 2028
Institute of Biostatistics and Analyses (IBA) is a spin-off company of the Masaryk University, with a share of ownership by the Masaryk University.
The company focuses mainly on the areas of project management of clinical research, real-world evidence (RWE) projects, organisation and management of clinical trials, particularly non-interventional clinical trials and health registries. This main activity is complemented with other services such as market access support, cost-effectiveness analysis, pharmacovigilance, analysis of clinical data, development of tailored software products and graphic design.
Location: Dresden, Germany
Certification period: 2023 - 2027
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.
Location: Marburg, Germany
Certification period: 2016 - 2020
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.
Location: Leipzig, Germany
Certification period: 2019 - 2023
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.
Location: Cologne, Germany
Certification period: 2020 - 2024
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.
International Certified Data Centres
As part of the pilot project carried out in Asia, a small number of data centres have been certified beyond Europe and a number of international auditors have been trained.
The following centres outside of Europe have received ECRIN Data Certification:
Location: Nagoya, Japan
Certification period: 2020 - 2024
Location: Foundation for Biomedical Research and Innovation at Kobe (FBRI)-Kobe, Japan
Certification period: 2019 - 2023
Location: Seoul, South Korea
Certification period: 2020 - 2024
In the context of its trial support activities and projects, ECRIN works with multiple partners across Europe.
Discover Other ECRIN Partners