Clinical trials in and with children are indispensable in order not to exclude our patients from medical progress. From the planning stage until the final implementation of a clinical trial, our medical and scientific actions are guided by an effort to minimise risks and stress for our young patients.
The Department of Paediatrics and Adolescent Medicine at the Universitätsklinikum Erlangen has been involved in paediatric clinical trials for many years, its actions naturally including vaccine trials, registration trials and investigator-initiated trials.
In order to meet the increasingly complex regulatory requirements for the conduct of clinical studies and to ensure highest quality standards, the Centre for Paediatric Clinical Studies was established in 2007.
All employees of the Centre for Paediatric Clinical Trials possess comprehensive expertise in the medical care of children and have perennial experience in the planning, organisation and conduct of paediatric clinical trials.
Our study assistants are registered nurses, medical and technical assistants or physician’s assistants who have completed additional study nurse training and who regularly continue their education.
Support to industry-sponsored clinical trials:
Support to investigator-initiated/non-commercial trials:
We closely cooperate with the Erlangen Center for Clinical Studies (CCS).
To date we have conducted both investigator-initiated trials and industry sponsored studies in the following areas:
All our activities are in line with the legal requirements and quality standards as laid down in national (German Drug Law, Medical Devices Act, GCP-V) and international guidelines and legislations (ICH-GCP, Directive 2001/20/EC, Paediatric Regulation (EC No 1902/2006), Declaration of Helsinki). In order to meet these requirements, we have established standard operating procedures (SOPs) for all areas so as to secure a high quality standard for all involved parties.
Tel: +49 9131 85-41203