Our project management services include: Project Management Protocol Development Study set-up, assistance with contract negotiations, investigator recruitment (site identification, selection and feasibility if required) Budget Development/Negotiations/Tracking Organization and preparation of investigator's payment Trial Master File set-up and maintenance Review of monitoring reports Web based access to study states Investigator and CRA meetings (planning and organization) 3rd party collaboration (e.g. drug supply, central labs, CRF printing, etc.) For monitoring purposes we have a dedicated team of well-trained clinical research associates (CRA), both locally and centrally, who provide consistent and effective monitoring of and interaction with the study sites. Our clinical research associates are continuously trained in study monitoring guidelines, other applicable regulations and disease pathophysiology relevant to the study. FGK Clinical Research GmbH Heimeranstrasse 35 80339 Munich Germany T | +49 (0) 89 893 119-0 F | +49 (0) 89 893 119-20 www.fgk-cro.com info@fgk-cro.com