Lutz H. Gegenheimer, MD Reporting and Consulting Services in Clinical Pharmacology Goerresstrasse 5 D-68259 Mannheim Phone:  +49-621-799 20 85 Fax:  +49-621-799 20 86 Email:
Range of services Integrated Clinical Study Reports according to the ICH E3 Guideline and sponsor SOPs Clinical Study Protocols Clinical Expert Reports Investigator's Brochures, INDs and other types of summary documents Publications in the field of Clinical Pharmacology Advisory services (study design, regulatory affairs etc) Key monitoring visits, CRF design, study coordination Professional career and academic studies Independent freelance medical writer and consultant for Clinical Pharmacology since 1995 Two years' training in toxicology and neuropharmacology in the pharmaceutical industry Four years' employment at a full-service CRO focussing on Phase I projects (planning, clinical conduct, biostatistical analysis, medical writing) in different positions, finally as head of the Department of Biometrics and Reporting Study of medicine at Hanover Medical School and the University of Heidelberg, Germany Four-year degree in psychology from the Technical University of Braunschweig, Germany Professional associations Member of the European Medical Writers Association (EMWA) Member of the American Medical Writers Association (AMWA)