Renu Singh-Mokashi

Over 3 years experience in medical and scientific writing in preparing Phase I to Phase IV Clinical Study Reports (CSR), Annual Safety Report (ASR), Clinical study protocols (CSP), Informed consent (ICF), Investigators’ Brochure (IB), Patient narratives, CTD summaries, Abstracts and others scientific support documents.

Over 5 years working experience in clinical research industry. Over 4 years working experience in clinical monitoring as a CRA and last 3 years in clinical trial management including medical writing and project planning for in house and out sourced projects (phase I, II, III and IV) as lead manager. Exposure to critical aspects of the clinical development process of pharmaceutical products (NCE and Generics). Exposure to clinical and developmental regulations of US-FDA, EMEA, MHRA; ICH-GCP, Indian GCP and Schedule Y.