SciMed Writing LLC (Science Works Division) offers medical, scientific, and technical writing services as well as paralegal and document quality management services to the biomedical research community and academia.
We provide infusion of biomedical expertise and statistical acumen with thoughtful and comprehensive data interpretation. Insightful observations of patterns and trends. Thorough and pervasively accurate accounting and keen awareness of minute but noteworthy research details. Plausible, evidence-based arguments. Comprehensive treatment of study objectives and endpoint-driven conclusions.
See Brochure. Clinical Research Documents for study Phases I to IV (Clinical Study Reports [CSRs], Protocols, Investigator Brochures [IBs], Integrated Summaries of Safety and Efficacy [ISS/ISE], submission-related document modules for Investigational New Drug [IND] and New Drug Application [NDA] support, electronic Common Technical Documents for Registration of Pharmaceuticals for Human Use [eCTD] including Module 2 summary documents and Module 5, Clinical Overviews [COs], Briefing Documents [BDs], Labeling Documents, and Agency Responses [domestic and international])
Pharmacovigilance (annual and periodic safety update reports [PSURs] and serious adverse event [SAE] patient/case narratives),
Publications (professional and academic), Clinical Trial Disclosure & Transparency. Familiar with standard research documents, electronic document management, tracking and review systems, and content or style guidelines (i.e., American Medical Association [AMA] and International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use [ICH]).
See Brochure. Standard Operating Procedure (SOP) Design, Corporate Training and Learning Management Systems (LMS),Quality Management, Healthcare & Science Education Program Support (i.e., standardized test question preparation or review), Grants, Laboratory Reports
Copy editing in English (spelling, grammar, punctuation, word usage, and sentence structure). Proofreading for flow, satisfactory treatment of objectives, proper data sourcing, data point accuracy, grounding of arguments, and internal consistency.
See Brochure and Regulatory Writing services above. Staff includes licensed healthcare professionals with clinical experience and scientific backgrounds.
See Brochure. Medical Writing, Document Quality Review/Editing, Pharmacovigilance Science.
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