Since the beginning of April 2022, Claire Borde joined the Qserve Group as a consultant where she works as a medical writer for Qserve CRO. Claire is based in France and has worked in the Clinical Research area for many years. She has a lot of experience in the field with regulatory aspects of Clinical Investigations in different countries.
Claire has over 13 years of experience in Clinical Research where she has worked in different environments (investigational sites, sponsors, and CROs): She held various positions, such as site's study coordinator in Investigational sites, sponsor CRA in a big pharmaceutic laboratory, Studies Start-up/submissions specialist for France in big CROs and Regulatory affairs Project Manager for Medical Devices clinical trials in Europe.
She worked in Cosmetics, Drug and Medical Devices areas, in various pathologies areas (Cardiology, Nervous central system, Rare Diseases, Genetic Disorders, Diabetes and other Metabolic Diseases, Oncology, Ophthalmology, Urology), and different contexts (pre-market & post-market studies, pediatric studies, interventional & noninterventional studies).
Before working in the Clinical Research area, she worked in water treatment research and she has a PhD in Transmissible diseases and tropical pathologies from the Faculty of Medicine of Marseille II, Marseille, France. She is a Certified Clinical Research Associate as well. Her education and her various work experiences allow her to have an overview of the clinical research environment and to combine her skills in the service of medical writing.
The key expertise areas of Claire:
- Development and/or Review and validation of regulatory aspects of Clinical Investigation plans, protocols, investigator brochures, labels, master ICFs and other relevant regulatory documents, Annual Progress Reports, and Clinical studies reports.
- Coordination of Ethics Committees, Regulatory Agencies, and other relevant bodies submissions in European countries for pre-market and post-market Medical Devices Studies.
- Drafting master regulatory documentation for submissions (cover letters, application forms).
- In France studies submissions to Ethic Committees and Regulatory Agency (ANSM), declaration of compliance to Reference Methodologies (related to EU and French Data Protection regulations) to the French Dara Protection Authority (CNIL) for Drugs (phases IIb to IV) and Medical Devices studies (post-market, pre-market, interventional & observational studies).
- Customization of studies documents for compliance with French requirements.
- High knowledge of ISO14155:2020, EU MDR 2017/745, EU GDPR 2016/679, ICH/GCP, and French Regulations related to Medical Devices and Drug Studies
- Mediate knowledge in EU MDR 2017/746, Italian, Spanish, German, Dutch, Belgian, and Austrian countries’ regulations related to Medical Devices studies.
- Advice to clients on regulatory issues relevant to conformity assessment, clinical evaluation, submissions strategy, studies classification, in relation to European and national medical device regulations and other relevant regulatory requirements
- Development of Clinical Performance Review Reports
- Scientific and medical bibliography
- Writing scientific articles
- Participation in the development of regulatory surveillance databases and procedures.
- Regulatory surveillance of national, and international regulations and requirements for clinical research, adverse events reporting, and other regulatory activities in European countries
- Investigational sites initiations, monitoring, and closure visits
- Remote Sites Monitoring
- Sites’ Contract negotiations
- Languages: French (native speaker) English (professional); Spanish and Italian (scholar).