Ralf Freese Medical Director Director, Business & Corporate Development [email protected] CTC North GmbH & Co. KG Martinistraße 64 20251 Hamburg, Germany Saskia Borregaard, PhD Director, Clinical Trial Management [email protected] BVMA member since 2014 Audit passed in 2014 Tel. +49 40 524719-0 Fax +49 40 524719-199 www.ctc-north.com HISTORY AND MISSION SERVICES Clinical Trial Center North (CTC North) is a CRO located at the University Medical Center Hamburg-Eppendorf. 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. Since 2006, CTC North has been providing a comprehensive range of professional services for clinical Phase I-IV trials. General Services ▷ Complete clinical trial management for UKE researchers as well as for the pharmaceutical, biotech and medtech industry ▷ Support services for clinicians managing European Research Grant applications ▷ Professional recruitment (patients, healthy and special populations) ▷ Monitoring ▷ Data Management and Biostatistics ▷ Medical Writing ▷ Quality Management ▷ Advisory and consulting services for all aspects of clinical development and conduct ▷ Professional training courses for investigators and study nurses (GCP, German Drug Law, Medical Device Law) HIGHLIGHTS Dedicated Phase I research facility, including 34 overnight beds; 12 beds with intensive monitoring capability Emergency infrastructure (ICU) within the University Medical Center to ensure qualified emergency aid, especially for first-in-man trials 42 Phase I Services ▷ Planning, clinical conduct and analysis of Phase I trials from first-in-man up to proof-of-concept providing a link between healthy volunteer and early patient trials Sleeping Laboratory with 11 PSG-beds on site (in cooperation with Hamburg University’s center for sleep medicine) ▷ Full Phase I trial setting with a highly experienced core team and state-of-the-art Modular concept of projects, offering individually tailored project designs from full-service packages to clinical conduct only ▷ Multi-center study management and monitoring ▷ Clinical conduct of Phase II to IV trials in a professional university setting ▷ Close collaboration with clinical and research specialists at the UKE and other Certified according to ISO 9001, a standard focusing on quality management ▷ A large pool of highly experienced research nurses V M A facilities and equipment Phase II-IV Services institutions in the Hamburg area V M A 43