Clinical Investigations, Clinical and pre-clinical studies

The success of clinical studies essentially depends on professional study management: Clinical studies are after all subject to national and international criteria and follow ethical principles. MedUni Vienna advises and supports doctors and scientists as well as partners of industry in planning, conducting and evaluating clinical and pre-clinical research projects.

The Clinical Trials Coordination Centre

The Clinical Trials Coordination Centre (KKS) founded in April 2008 by the Medical University at Vienna is one of the first consultation centers for clinical research in Austria. The consultation offer of the KKS covers all areas of the management of clinical studies: The KKS plans clinical studies, carries them out and evaluates them. The procedure as per current internal standards (SOP) is thus the pre-condition. The following services are offered in parts or comprehensive support: 

• Consultation and management 
• Project management and monitoring 
• Submission and notification to officials and Ethics Commissions (Regulatory Affairs) 
• Developing the master policy for clinical studies
• Preparing electronic Case Report Forms (eCRF)
• Data management
• Ongoing safety monitoring of trial subjects (pharmaco-vigilance)
• Preparing logs, test plans and GCP-compliant conclusive reports (Medical Writing) 
• Initial and continuing education: Good Scientific Practice, further education events
• Cooperation with employers from industry
• Free consultation for employees of the MedUni Vienna
• Pediatric module OKIDS (studies on children) 

KKS guarantees that study data is consistently interpreted through close cooperation with doctors, data managers and statisticians, and an internal quality management system. The KKS offers the consultation, planning and support of some parts herewith, or even the complete assumption of a clinical study. Parts may relate to project management, performance of monitoring or preparing the case report form and other study documents, for example. The offer is agreed upon in a personal consultation on respective requirements. Costs are calculated accordingly, where there are affordable tariffs for academic research projects.

Team Regulatory Affairs for Medical Devices/IVDs

The Regulatory Affairs team for medical devices/IVDs offers regulatory consulting, planning, and support for the development and submission process for clinical investigations of medical devices/performance studies of IVDs.
The service is tailored to your specific requirements in a personal consultation and includes the following areas:

• Provision of proven and compliant templates
• Review of the technical documentation required for submission to the ethics committee and national authority.
• Creation of a targeted intended purpose for your investigational device
• Determination of the risk class in accordance with the applicable classification rules and guideline documents
• A comprehensive risk analysis in accordance with EN ISO 14971
• Preparation of the necessary technical documentation for your investigational device for submission to the ethics committee and national authority (BASG)
• Consulting and support during the submission process to the national authority until a positive implementation decision is issued

Our internal test laboratory would be delighted to provide you with:

• Consulting on medical device safety in accordance with IEC 60601-1
• Performing safety tests for medical electrical equipment in accordance with ISO 17025 for accredited test laboratories
• Fundamentals of electromagnetic compatibility in accordance with IEC 60601-1-2
• Setting up the Usability Engineering File and performing formative and summative testing with lays and clinical experts in various disciplines

Core facility laboratory animal breeding and husbandry

Preclinical research is the engine of scientific progress and the basis for tomorrow's medical therapy. The "Core Facility Laboratory Animal Breeding and Husbandry" (CFL) of the Medical University of Vienna enables scientists to conduct animal experiments in the field of biomedical research within the strict legal requirements. CFL consists of several functional units with different levels of hygiene for breeding and keeping laboratory animals. The main task of the CFL team with its veterinarians, animal keepers and technical staff is to keep and care for the animals used in the researchers` scientific projects.

Center for Biomedical Research and Translational Surgery (CBR)

The Center for Biomedical Research and Translational Surgery (CBR) offers a comprehensive portfolio of services for both internal and external clients. The facility comprises four fully equipped operating rooms, one hybrid operating room, and three procedure rooms, as well as dedicated animal housing facilities for both large and small animal models.
The CBR provides the following services:

• Consulting on the planning and execution of preclinical GLP and non-GLP studies 
• Preparation and submission of applications and notifications to the Animal Ethics Committee and the responsible ministry (Regulatory Affairs) 
• Preparation of study protocols and other study documentation (Medical Writing) 
• Project management for preclinical GLP and non-GLP studies 
• Continuous monitoring of laboratory animals during acute and chronic studies 
• Data management, including the development of case report forms (CRFs) and preparation of study data for statistical analysis 
• Education and training: Continuing education programs in collaboration with the Medical University of Vienna's Human Resources Development Department (e.g. FELASA-accredited courses for PhD students and MedUni Vienna staff working with laboratory animals) 
• Training courses for physicians on the use of novel implants and robot-assisted surgery using the Da Vinci Surgical System 
• Application of state-of-the-art technologies, including eye-tracking, for the training of surgeons 
• International collaboration: Participation in European research consortia conducting multinational preclinical studies 

The CBR is certified according to DIN EN ISO 9001 and ISO 14001 and holds Good Laboratory Practice (GLP) certification, ensuring compliance with the quality standards required by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Most modern operation rooms, laboratories and animal enclosures guarantee successful and research projects appropriate for the species. All projects are carried out as per Good Scientific Practice guidelines of the MedUni Vienna. Animal Ethics Commission supports in producing and submitting applications.