Dr. Saskia Borregaard
PRECIOUS Team CTC North
Dr. Iris Alpers
The Clinical Trial Center North (CTC North) is an independent full service CRO located on the campus of the University Medical Center Hamburg-Eppendorf (UKE). Its objective is to guarantee the professional conduct of clinical trials in accordance with ICH-GCP, the German Drug Law (AMG) and the German Medical Device Law (MPG) within a university environment. CTC North provides professional services in all aspects of clinical trials and offers complete clinical trial management complying with regulatory guidelines valid worldwide and the highest quality assurance standards. CTC North acts as an advisor to investigators and scientists and provides a variety of support services related to conducting clinical trials. CTC North has extensive experience with the coordination of multicenter clinical trials, with a focus on studies with non-commercial sponsors (IITs). The following services are provided: Project management, regulatory services, medical writing, safety monitoring, monitoring, data management, and statistics.
With the PRECIOUS study CTC North and UKE continue their successful history of collaboration in clinical stroke research with coordination of European stroke trials.
Main tasks attributed in the project:
CTC North contributed to WP6 (Safety monitoring) together with UKE. The overall aim of the PRECIOUS trial was to improve the treatment of patients with acute ischaemic stroke or intracerebral haemorrhage. Thus, the safety of patients was of highest priority throughout the enrolment in the clinical trial. The main responsibility of WP 6 was to assure the safety of the patients enrolled in the clinical trial by
Documentation and evaluation of all reported SAEs
MedDRA Coding of SAEs
Reporting of SAEs and SUSARs to the relevant authorities
Development of Annual Safety Reports (DSUR)
Development of Final Safety Report
Preparation of SAE / SUSAR Listings for the DSMB
and perform a continuous risk/benefit evaluation and consideration based on the above named actions.
CTC North also contributed to WP1 (Trial Management) and was responsible for national regulatory submission and trial coordination in Germany together with the UKE.