The Translation of Research to the ClinicCopyright: saveenergysystems
The Medical Science and Technology profile area places emphasis on the development of methods and products, seeking to fill a gap in the value chain, as it is often not possible to see the ideas through to their implementation in healthcare. Here, the focus is on the independent areas: the development of new medical products and the first application of new pharmaceuticals.
In order to provide a basis for the implementation of clinical studies and trials in accordance with internationally recognized quality standards as well as legal provisions such as the Medicinal Products Act, the Faculty of Medicine established the Clinical Trial Center Aachen, CTC-A for short, in November 2010.
The CTC-A supports clinics, departments and institutes of RWTH Aachen and affiliated institutions in the approval process for and implementation of clinical trials. Furthermore, it provides assistance with project, quality, and risk management. For individual projects, the CTC-A has provided support with product development and the translation of research into clinical practice.
Such work often begins many years before clinical trials with humans can be performed. This applies in particular to the field of regulatory affairs, that is the structured determination and application of requirements in accordance with the pertinent provisions, norms, and guidelines for national and Europe-wide studies.
A particular challenge is to continually create Common Technical Documents in the development process of medical products as well as Investigational Medicinal Product Dossiers in the case of pharmaceuticals. Furthermore, the risk file must be continually maintained and updated. The CTC-A supports and advises the developer teams in all the above activities.
In general, the CTC-A can be seen as an interface between research and clinical practice. In order to make it possible for all types of projects and all RWTH researchers to use this interface for trials of newly developed devices and pharmaceuticals, it must be constantly expanded in accordance with the requirements formulated by the engineers, life scientists, and medical experts that make use of it. The Center for Translational & Clinical Research Aachen is responsible for initiating and supervising this process.
Center for Translational & Clinical Research Aachen (CTC-A)Copyright: MedST
The Clinical Trial Center Aachen takes on these new responsibilities by establishing and integrating a new division, titled Translational Project Management. Led by the former coordinating manager, the new center has been renamed Translational & Clinical Research Aachen.
The spokesperson for the profile area Medical Science & Technology is automatically also a member of the Board of CTC-A.
In summary, it can be said that the CTC-A has undergone a process of partial rebranding, naming the old and new responsibilities of the institution in its designation.
Under the umbrella of the CTC-A and led by a quality manager, who is also head of translational project management, a new team has been established, consisting of a project scout, a pre-clinical manager, a phase I manager, an IT manager, and the Regulatory Affairs officer.
The new team acts as an interface between the profile area Medical Science & Technology, the CTC-A, and the scientists and engineers involved in the research and development projects.