Medical Writing Services

Protocol design and development; Design and preparation or input into study documents (study committee charters, adjudication manuals, study operation manuals, scripts, CRF, CRF completion manual, etc.); Input into statistical plan and table shells; Interpretation of clinical data and preparation of CSR according to ICH standards; Preparation of Integrated Summaries of Efficacy (ISE) and Safety (ISS) for regulatory  submissions; Systematic data reviews; Review or preparation of abstracts and manuscripts for publication in peer-reviewed journals; and, Preparation of risk-benefit and risk management documents.