Clinical studies and research
Our engineering community has a long expertise record in multidisciplinary collaboration with many (inter)national university and general hospitals.
One of our major partners is the HIRUZ Clinical Trial Unit (CTU) of the Ghent University Hospital, recognized for its expertise in the support and advice in submissions and monitoring of academic clinical research projects.
Services include the following:
Support in the preparation of a correct and complete submission package for the Ethics Committee and Competent Authority, if applicable.
Guiding the investigator in reporting to the Ethics Committee and/or the Competent Authority: amendments, safety reporting, annual progress report, end of study reporting, notifications, …
Performing on-site and remote monitoring according ICH-GCP for all clinical trials with medical products and medical devices for which Ghent University (Hospital) is a sponsor. Monitoring can also be provided for other trials, upon request.
Providing support and advice in Biomedical Research Data Management using best practices and appropriate software to improve efficiency and comply with the regulatory obligations.
Guiding investigators and providing advice in the development of a trial.