P.R.I.S.M.A. is a German Clinical Research Organization (CRO) and dedicated to support the European portion of the pharmaceutical and biotech industries’ clinical development programs. We offer the following customized services either on a stand alone basis or as part of an integrated “full-service” solution: • Feasibility for national and pan-European clinical trials • Development of study design and study protocol • Development of paperbased Case Report Forms (CRFs) • Preparation of all study related documents • Recruitment of study sites • Contract negotiations with study sites • Insurance handling • Request for authorization of clinical trials at competent authorities • Submission of clinical trials to Ethics Committees (ECs) for favorable opinion • Training of the study personnel • Planning and conducting of investigator meetings • Clinical project management • Clinical monitoring (phase I - IV) • Payment of investigator and/or study personnel fees • Study supply management • Pharmacovigilance / Drug safety • Medical monitor • Legal Representative Services These services can support both European and locally managed projects.