About

History

Located in Ann Arbor, Michigan, Salerno Scientific LLC was formed in April 2007. Specialties include oncology and cardiovascular therapy areas, preclinical studies, and Phase 1-3 trials. Consulting has included Dendrix, a research firm in São Paulo, Brazil; Progenics Pharmaceuticals in Tarrytown, New York; and Immunomedics in Morris Plains, New Jersey; and Esperion in Ann Arbor.

Expertise

Projects include: clinical study reports (CSRs), Modules 2.7.3 Summary of Clinical Efficacy, 2.7.4 Summary of Clinical Safety, briefing documents, orphan drug applications, SOP manuals, informed consent documents, pediatric study plans (FDA), paediatric investigation plans (European Medicines Agency), Statistical Analysis Plan reviews, style manuals, establishing strategies and timelines for project management. Seminars available for ICH, the Declaration of Helsinki, Good Clinical Practice, Statistics in Medicine, and Medical Writing in English.

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