General Information

Video

Unit 40 - Support of Clinical Studies - Hannover Clinical Trial Center

Objectives

Hannover Clinical Trial Center (HCTC) is an academic contract research organization (CRO) capable of providing clinical trial management services, pharmacovigilance, and monitoring services. Special emphasis is given to clinical studies employing cell and gene therapy products. HCTC combines the clinical expertise and academic leadership of a premier German teaching hospital with the full-service operational capabilities of a contract research organization. Clinical trial support: 

• Set-up of knowledge database for regulatory and legislative issues related to ATMPs (advanced-therapy medical products)  
• Preparation of GCP compliant SOPs for initiation and conduct of clinical trials with special emphasis on advanced-therapy medicinal products
• Guidance in product development in preparation of first-in-man (FIM) clinical trial 
• Regulatory approval process of clinical trial protocols employing ATMPs  
• Project management of clinical trials 
• Clinical monitoring 
• Data management
• Safety and pharmacovigilance supervision in conjunction with pharmacovigilance-qualified person (QP) from HCTC; setting-up of electronic reporting system in compliance with the ICH-E2b Guideline

Academic Collaborations

• Prof. C. Klein, Hannover Medical School, Pediatric Oncology, gene therapy 
• Prof. C. Baum, Hannover Medical School, Experimental Hematology, vector optimization 
• Prof. A. Haverich, Hannover Medical School, Department of Cardiothoracic, Transplantation and Vascular Surgery, clinical study program 
• Prof. E. Mischak-Weissinger, Hannover Medical School, bone marrow transplantation 
• Dr. M. Sauer, Hannover Medical School, Pediatric Oncology, stem cell therapy 
• Prof. M. Manns, Hannover Medical School, Department of Gastroenterology 
• Prof. D. Reinhardt, Hannover Medical School, Department of Pediatrics 
• Prof. R. Stripecke, Hannover Medical School, Department of Hematology and Oncology

Equipment and Service Facilities

[Please find a list of all available equipment here]

Publications

[Please find the publications of this workgroup here]

Further Information

http://www.clinical-trial-center.de
info(at)clinical-trial-center.de

Staff