Document Types

My services focus primarily on medical, clinical or scientific content. For example, in the context of a marketing authorization (MA) dossier in CTD format, they mainly cover Modules 2 and 5.
The list below is not exhaustive; any other medical, pharmaceutical or clinical documents not mentioned can be considered on a case-by-case basis.

•  Regulatory documents related to human medicines, including summaries of product characteristics (SmPCs), package (information) leaflets and labeling.
•  Clinical trial documents, such as protocols and amendments, informed consent forms, case report forms (CRFs), clinical study reports (CSRs) and investigator’s brochures (IBs).
•  Pharmacovigilance documents, including periodic safety reports (PSURs/PBRERs/DSURs) and individual case safety reports (ICSRs).
•  Clinical outcome assessments and patient questionnaires (COAs/PROs) used in clinical trials.
•  Therapeutic recommendations and guidelines.
• Health communication materials for patients and healthcare professionals, including information sheets, therapeutic patient education programs (ETPs), guides and brochures.
• Medical and clinical documents, such as discharge letters, consultation notes, hospitalization reports, drug prescriptions and laboratory test results.
•  Scientific publications, including research articles and literature reviews.
•  Science articles for a general audience covering various health topics…