Introduction
The aim of the Julius Trial Unit is to support several aspects of clinical and epidemiological research. We provide an outpatient research center, equipped with the necessary facilities to conduct clinical phase II/III trials in accordance with Good Clinical Practice guidelines. The clinic supports both academic and commercial studies (both pharmaceutical and food industry).
Expertise
We provide information, advice, guidance and training relevant for the conduct of clinical trials. Our research nurses can also assist in drawing up patient information and informed consent forms, source documents, flow sheets, drug accountability logs and study files. During meetings with the investigator or sponsor the study specific requirements for data collection are determined.
In conjunction with our colleagues from the epidemiology and data management sections of the Julius Center, we are able to offer help from protocol design to analysis and reporting.
During the performance of the trial we will use a project management system (Accolade©) and a participant management system. These systems can be configured to support the common daily study logistics and administration process. Progress reports can be provided at any time.
The well equipped Trial Unit can accommodate studies that require subjects to stay all day or to only come in for a short appointment. Clinical services include but are not limited to study visits, blood samples and storage (biobank available), on-site laboratory, ECG facilities, abdomen fat images by ultrasound, DEXA scans, IMT measurements of the carotid artery, measurement of pulse wave velocity and pulse wave analysis. Apart from conducting complete studies it is of course possible to carry out certain measurements for studies which are running elsewhere.
Sometimes we are able to provide short-term personnel (research nurses, etc.) to fill temporary deficiencies of research personnel in institutes, provide additional manpower or render professional assistance for a certain period of time.
Quality
Our studies are always performed according to ICH-GCP regulations. The department uses a Quality Management System and was certified according to ISO 9001 in January 2005. The Trial Unit is undergoing both internal and external audits.
Experience
The Trial Unit has a history of over 10 years. We have been participating in a large number of single- and multi-center studies, ranging from small, complex phase II studies with about five subjects to large phase III studies with hundreds of subjects. Documented standard operating procedures (SOP’s) are available for each procedure carried out in the Trial Unit. We have a proven track record of high recruitment rates and high quality output. Drop out rates are traditionally low. Recruitment infrastructure includes our own database (more than 4,000 volunteers), the local municipality, advertisements and collaboration with GPs and specialists.
Team
Our staff is highly qualified, experienced, enthusiastic and motivated. All members are well-trained and dedicated to clinical research. Teamwork is crucial and collaboration with sponsor or investigator is essential to all aspects of our work. The staff includes research physicians, research nurses, trial assistants and project managers. All of them are exclusively employed for research duties and activities associated with clinical research.
Contact: Lizeth Vendrig