Dorothee Oberdhan

Lead program level development of clinical outcome assessment (patient and observer/caregiver reported outcomes) strategies as well as contribute to the development of health economic strategies and their implementation in clinical trials. Preparation of publications and poster presentations. Contributor for NDA and lead for FDA advisory committee meeting preparations. Oversee management of clinical trials for drug development programs.

Manage clinical trials. Conduct pre-study, initiation, routine monitoring and close-out visits (phase 1-3) . Implementation of a multinational observational study to investigate treatment patterns and outcomes of 2351 newly-presenting LUTS/BPH patients in 6 European countries over a 1-year follow-up period. Submission and correspondence with ethics committees and regulatory authorities.