The KKS Heidelberg at the Medical Faculty Heidelberg, was initially funded by the German Ministry of Education and Research (BMBF) and the Medical Faculty. More than 50 staff members support the entire spectrum of clinical research within the scope of planning, conduct, analysing, and interpretation of innovative clinical trials according to the applicable regulations and international guidelines, e.g. Good Clinical Practice (ICH-GCP). The KKS Heidelberg has been working effectively since July 2000 and has been evaluated in several audits and expert assessments with favourable outcomes regarding the quality and efficiency of its work-flows and procedures. KKS Heidelberg is involved in some innovative phase I to IV trials carried out according to German Drug Law as well as in projects pursuant to Medical Device Law, including in-vitro diagnostics and innovative therapeutic agents (e.g. ParvOryx in oncology or Myrcludex in infectious disease). All activities are being executed according to the Standard Operating Procedures (SOPs) of the KKS Heidelberg being based on ICH-GCP guidelines and applicable regulations. In order to comprehensively ensure a high quality, an adequate patients' protection, a compliance with ethical and legal requirements as well as the employment of adequate research methods the KKS Heidelberg provides the following services to clinical trials: Project Management and Regulatory Affairs, Quality Assurance, Clinical Monitoring, Pharmacovigilance, Data Management and Biometrics.