Claire has experience in planning and preparing Clinical Evaluations, varying from writing Clinical Evaluation plans and reports to performing Literature searches and preparing Post-Market Clinical Follow-up strategies and plans.
Within Qserve, Claire focuses on biomedical statistics, from study design to data analysis. She advises on the rationale and considerations in statistical methods, study design, and sample size calculation.
The key expertise areas of Claire
- Clinical Evaluation of medical devices, including the preparation and review of Clinical Evaluation Plans and Clinical EvaluationReports (MEDDEV 2.7.1/rev. 4 and EU MDR)
- Preparation of Literature Search Protocols and Data Collection Reports (MEDDEV 2.7.1/rev. 4 and EU MDR)
- Performing gap analyses concerning Clinical Evaluation and Clinical Investigation under the EU MDR
- Study design for pre- and post-market clinical studies (ISO 14155 compliant)
- Study type selection and sample size considerations
- Data analysis and statistical support (e.g. parametric and non-parametric tests, linear and logistic regression)
- Experienced medical writer
- Planning, preparation and executing of clinical trials
- Clinical experience with patients, respiratory assistance and monitoring
- Technical knowledge on pulmonary function testing (e.g. spirometry)
Claire is currently finishing her PhD in pulmonology. Herewith, she gained experience in project management, clinical data analysis, medical writing, and critical appraisal of literature. Additionally, she follows epidemiologist training, aiding her knowledge on study design and statistics. As part of her PhD, Claire acted as commissioned investigator in a multinational multicenter trial. She therefore was charged with patient inclusion, data management and collection.
Prior to her PhD, Claire obtained a master’s degree in technical medicine. In her studies she specialized in medical signaling, primarily approached from a pulmonary point of few. As a technical physician, Claire has a registration under the Individual Healthcare Professions Act (Dutch Wet BIG) and worked in close contact with physicians, while having numerous patient contacts.
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