Particular expertise and experience in writing clinical study reports, protocols, protocol amendments, patient information leaflets (informed consent) and Investigators Brochures.
From a background as a CRA progressing to Project Manager and European Project Team Leader, 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 treatment and palliative support, (chemotherapy, viral vector, targeted agents, photodynamic therapy, radioenhancement) cardiovascular, CNS (ADHD, epilepsy, migraine, Parkinson’s disease), dermatology, endocrinology, gastrointestinal, genitourinary medicine, haemophilia, musculoskeletal, ophthalmic preparations, radiopharmaceuticals, respiratory medicine, and vaccines.
More than 100 clinical study reports in phases I to IV (mostly phases I to III) written to ICH E3.
Experience also in writing protocols, protocol amendments clinical summaries, clinical overviews, clinical expert statements, PIPs, ODDs and responses to regulatory questions.
Literature reviews and monographs.