The Institute of Medical Biometry and Informatics (IMBI) of the University of Heidelberg is headed by Professor Meinhard Kieser, PhD, and is divided in the section of Medical Informatics and in the department of Medical Biometry, which partners this project. The department of Medical Biometry consists of 23 scientific researchers, 5 data managers and 6 administration staff members and has a long-standing and broad experience in design, conduct, and analysis of clinical Phase I-IV trials. A central data management unit performs data quality processes in accordance with the approved SOPs of the IMBI in order to ensure an efficient and GCP-compliant implementation of the ongoing clinical trials. In addition, four working groups have been established in order to provide expert knowledge and to develop statistical methods in clinical trials, meta-analyses, statistical modeling, and statistical genetics.
The IMBI Heidelberg is responsible for statistical planning, randomisation, data management, statistical support, and analysis of the pilot randomised controlled trial in WP 6.