Ms. Anne McDonough MPH
McDonough Clinical Research Ltd
Skills And Services Offered:
Having worked in a number of clinical research roles, I bring a comprehensive understanding of the development process to your documents. From initial regulatory and operational documents through clinical study reports and manuscripts, I know how all these pieces fit together to support your product’s development, approval, and use.
• Clinical study reports
• Common technical document modules (nonclinical and clinical)
• Conference reports
• Investigator’s brochures
• Layperson’s summary
• Patient narratives
• Patient information sheets/informed consent forms
• Protocols and protocl amendments
I also have a lengthy background in clinical research compliance and can produce documents to support training and assessment activities.
• Assessment programmes
• Standard operating procedures
• Training materials
My experience includes a full range of medical products (biologics, medical devices, pharmaceuticals, vaccines) in a variety of therapeutic areas for clients from emergent biopharma companies and nonprofit organisations to multinational corporations.
I have a particular passion for and expertise in vaccines and infectious diseases but significant experience in a wide variety of therapeutic areas: cardiology, endocrinology, genitourinary medicine, haematology, HIV/AIDS, immunology, infectious disease, musculoskeletal, neonatology, neurology, nutrition, oncology (haematological and solid tumours), obstetrics/gynaecology, ophthalmology, paediatrics, pain management, psychiatry, pulmonology/respiratory medicine, radiology, urology, virology.
• Teach Medical Writing for Health Volunteer Studies workshop for EMWA
• Advanced certificate earned from EMWA
• Work conducted in accordance with your SOPs or with my established comprehensive set of SOPs, as you choose
• Expert and up-to-date knowledge of clinical research guidelines, applicable regulation and guidances, and publication ethics
• See my website (www.McDonoughCR.com) for client recommendations, writing samples, more details of my experience, and my blog.