About

History

Located in Ann Arbor, Michigan, Salerno Scientific was formed in April 2007. Specialties include oncology and cardiovascular therapy areas, preclinical studies, and Phase 1-3 trials. Recent consulting has been with Dendrix, a research firm in São Paulo, Brazil; Progenics Pharmaceuticals of Tarrytown, New York; Amarin of Mystic, Connecticut; MicroDose Life Sciences in Farmington Hills, Michigan; and AIS Consulting in Ann Arbor.

Expertise

Projects include: 510(k) submission for a medical device, clinical study reports, orphan drug applications, SOP manuals, informed consent documents, pediatric study plan (FDA), paediatric investigation plan (European Medicines Agency), Statistical Analysis Plan reviews, establishing strategies and timelines for project management, and style manuals. Seminars available for ICH, the Declaration of Helsinki, Good Clinical Practice, Statistics in Medicine, and Medical Writing in English.

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