Pharmaceuticals - Langenfeld, North Rhine-Westphalia, Germany
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.
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