McDonough Clinical Research Ltd Information

Professional medical writing and training services supporting pharmaceutical/biotechnology/medical device industry, academic investigators, and nonprofit organisations with research and development documents, manuscripts, and more Comprehensive regulatory submission services available, including templates for all CTD modules, medical writing (CMC, nonclinical, clinical), QC, publishing, submission, regulatory operations support, and project management Expert protocol writing based on >25 years' experience in clinical research operations, compliance, clinic science, and medical writing Document types: manuscripts, conference reports, CTD modules (nonclinical and clinical), clinical evaluation reports, clinical study reports, safety narratives, investigator’s brochures, development safety update reports, orphan designation applications, regulatory briefing documents, risk management plans, protocols, study manuals, subject information sheet/informed consent forms, training and evaluation materials Research types: clinical R&D (Phases 1 to 4), observational research, systematic review and meta-analysis, clinical guidelines, surveillance, and literature review. Experience: • Full range of medical products: biologicals, diagnostics, gene therapy, medical devices, orphan drugs, pharmaceuticals, photodynamic therapy, stem-cell therapy, vaccines • Variety of therapeutic areas: allergy, cardiology/vascular disease, dermatology, endocrinology, genitourinary medicine, haematology, HIV/AIDS, immunology, infectious disease, metabolic disease, musculoskeletal, neonatology, neurology, nutrition, obstetrics/gynaecology, oncology (haematological and solid tumours), ophthalmology, orphan diseases, paediatrics, pain management, psychiatry, pulmonology/respiratory medicine, radiology/imaging, urology, virology