|
Particular expertise and experience in writing clinical study reports and related regulatory documents From a background as a CRA progressing to Project Manager, Wendy Kingdom has an in-depth understanding of the processes and challenges of clinical research. This brings to her report and regulatory writing a realistic and practical knowledge of GCP, study procedures and study organisation Examples of therapeutic areas covered to date include anaesthesia, anti-inflammatory agents, cancer chemotherapy and palliative support, cardiovascular, CNS (ADHD, epilepsy, migraine, Parkinson's disease), dermatology, endocrinology, gastrointestinal, genitourinary medicine, musculoskeletal, opthalmic preparations, radiopharmaceuticals, respiratory medicine, and vaccines More than 80 clinical study reports in phases I to IV (mostly phases I to III) written to ICH E3 More recent experience in writing clinical summaries, clinical overviews and clinical expert statements Investigators brochures Literature reviews and monographs |