Over the past decade, I have performed most of the linguistic tasks in the end-to-end Clinical Trial Solutions, incl. the full cycle of pharmaceutical product development from Preclinical to Phases I-III stages:
• Clinical Trial Materials & Filings (PISs/ICFs, IBs)
• Pharmacovigilance & Safety (IRB/EC/IEC comm., SAEs, SUSARs)
• Drug Discovery & Development (export/import)
• Compliance & Regulatory (Phase IV/Sales, MAAs, EMA/FDA Comp.)
• Product Marketing & Launch (CSRs, SmPCs, FSNs, SmPCs)