Begriffe, Krankheiten, Einrichtungen u.v.m., verknüpft mit dem zuständigen Bereich.
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Special Services
The Clinical Trials Unit cooperates with a huge range of different facilities. In the following you will find a list with a short description of the most important cooperation partners.
Centre of Chronic Immunodeficiency (CCI)
The CCI is an independent clinic within the University Hospital devoted to immunodeficiency research, diagnosis and patient care. This innovative program allows biologists and medical specialists in various fields to work closely together, and to coordinate efforts in transferring the results of basic research into patient treatment. This shared knowledge and expertise also greatly contributes to the quality and care of patients suffering from chronic immunodeficiency disorders.
Link to CCI: http://www.uniklinik-freiburg.de/cci/live/index_en.html
KKS-Network (KKSN)
Clinical trials are essential for medical progress. The Network of Coordinating Centres for Clinical Trials (KKS Network) stands for comprehensive advice and support for planning, conducting and evaluating clinical research projects.
The network offers a wide range of scientific services on a regional and national basis to scientists in universities, hospitals and industry. Supported by the Federal Ministry for Education and Research (BMBF), the KKS Network is a platform for transparent, patient-oriented development of new drugs and therapeutic principles in Germany. Paediatric trials are supported in separate special modules.
Link to KKS-Network: http://kks-netzwerk.de
TREAT-NMD
(Translational Research in Europe - Assessment and Treatment of Neuromuscular Diseases) When conducting a clinical trial in Europe a lot of regulations have to be considered. Although there is a consistent standard (e.g. concerning clinical trials with medicinal products) there still remain many differences between the member states.
Particularly with regard to multi-centre studies the problems caused by the diverse implementation of European Directives into national law have to be overcome. Different national authorities, diverse procedures and various national distinctions hamper the planning and conducting of clinical trials.
This database should provide a valuable source of advice to people who are involved in the planning of mono or multi-centre clinical trials within different European countries.
The database contains contact addresses of national authorities as well as national legislation and documents.
Link to the Regulatory Affairs Database: http://www.treat-nmd.eu/regulatoryaffairs
About CTCC Treat-NMD
The Clinical Trial Coordination Centre was established in May 2007 as one activity of TREAT-NMD (www.treat-nmd.eu), a pan-European 'network of excellence' aimed at improving treatments and finding cures for patients with neuromuscular disorders. It was built up in collaboration with one of Germany’s leading Departments of Neuropaediatrics and Muscular Disorders and the Clinical Trials Unit of the University Medical Center in Freiburg, Germany. Both have longstanding experience in the field of neuromuscular disorders and in the conducting of clinical trials.
Link to TREAT-NMD: http://www.treat-nmd.eu
ECRIN (European Clinical Research Infrastructures Network)
Based on the connection of national networks of clinical research centres and clinical trials units, the EU-funded ECRIN programme consists of integrating national clinical research facilities into a pan-European infrastructure, able to provide support to multinational clinical research in any medical field, and for any category of clinical research. A first step (2004-2005, FP6 Health priority) helped identify bottlenecks to multinational cooperation. In the second step (2006-2008, FP6 Health priority), transnational working groups define procedures and guidelines for multinational studies in the EU. The third step (2008-2011, FP7 Infrastructure Unit) consists of building the European infrastructure for clinical trials and biotherapy, providing high-quality services to multinational clinical research.
This distributed infrastructure, based on the integration of competence centres will provide integrated ‘one-stop shop’ services to investigators and sponsors in multinational studies, with the local contribution of staff embedded in each national coordination (patient recruitment and investigation, data management, GMP manufacturing of biotherapy products, quality assurance, monitoring, ethics, regulation and adverse event reporting). In addition, consulting will be provided to investigators and sponsors upstream to the study (regulation, ethics, centre selection, cost, funding, and insurance).
These services are particularly relevant for academic clinical research, research on rare diseases, neglected diseases, and for clinical trials sponsored by biotechnology, drug, and device enterprises that may lack the capacity to conduct EU-wide studies. ECRIN will be a major tool for FP7 - or Innovative Medicines Initiative (IMI) - funded projects.
Hereby ECRIN will stimulate EU research on prevention, diagnosis and treatment, hence improving healthcare delivery to patients and citizens.
Link to ECRIN: http://www.ecrin.org
WHL – Wissenschaftliche Hochschule Lahr (Graduate School of Business and Economics Lahr)
Albert-Ludwigs-Universität Freiburg and the Graduate School of Business and Economics Lahr have been offering a joint postgraduate programme in the area of “Clinical Research Management” (Master of Science) since 1.10.2007. The blended learning postgraduate course prepares its participants for management positions in the area of clinical research. For this reason, it is aimed at managers and future managers in the pharmaceutical industry and in academic research facilities (medical centres), in particular biologists, chemists, pharmacists and physicians. The course involves a combination of distance learning, seminars and online components. The contact hours are held at the WHL.
Current dates and information about the Master of Science in Clinical Research Management can be found on the internet on the pages of the WHL or the Clinical Trials Unit. Friederike Mutz, the studies advisor at the WHL is available at any time for a one-to-one interview.
Link to WHL: http://www.akad.de/whl-lahr
