Imetics Information

IMETICS is a small Romanian CRO founded in 2013, having the people, resources and culture to respond to pharmaceutical and biotechnology clients’ drug development challenges. Since 2013 we are continuously providing the following services: • Medical review in oncology, diabetes and cardiovascular medicine. We have performed, and we accumulated experience in patient-profile-review based on eCRF, vital signs review, AE listing review, laboratory finding review. Currently we are working with a global CRO in 2 phase III oncology trials. • Medical writing (scientific article writing) in diabetes and cardiovascular medicine. Creating posters or presentations for these articles. • Data mining for all kind of phase II-III studies. As a result of the data mining we created either part of the marketing-authorization dossier (even for Germany – AMNOG dossier), or scientific articles. • Regarding the AMNOG dossier, together with one of our partners, we developed a tool, which permits creation and recreation of the AMNOG dossier, without needing specialized medical writers. The good part is, that in case of the AMNOG dossier is created, and the statisticians realizes, that some of the results are incorrect, our tool will recreate the dossier in about minutes, without the need of rewriting the whole dossier. • Quality assurance, quality check, for marketing authorization dossiers, trial dossiers, or scientific articles. • Pharmacovigilance services – narrative writing, narrative quality check, CV transformation and • Scientific translation (pharma and medical – for clinical trial documents, scientific articles or parts of the marketing authorization dossier). Our experts have more than 10 years of experience in this field, for the following four languages: English, French, Romanian and Hungarian. Basically, if a pharma company or a CRO (small, local or big global) needs some services, those services can be covered by IMETICS.