MedRes - Marcin Dudek

About me Medical Writer and Clinical Operations/Project Manager with over 20 years experience in Pharma Industry, working for small and large biotechnology/pharmaceutical companies and CROs. Offering flexible services in preparing and writing of various documents related to clinical studies (Phase I-IV, Bioequivalence, NIS, PASS, DUS), including, but not limited to the following: • Study Protocols, informed consent forms & patient information sheets • Patient leaflets & recruiting materials • Clinical Study Reports - to ICH E3 standards • SAE narratives • Study/Protocol Synopses • Investigators Brochures • Manuscripts, journal articles • Posters, abstracts & slide presentations. Also offering consulting in the field of local law requirements for study documents as well as setting, management and co-ordination of clinical projects in Poland. Preparing documents in Polish language as required by Polish authorities and offering translation of study documents into Polish.