My commitments: protecting participants, ensuring reliable data

Every mission applies current regulations and proven methods, for the safety of people taking part in research and the quality of your study data.

Regulatory compliance comes first

I work to current texts and follow their updates:

ICH E6(R3) Good Clinical Practice, effective in the EU since July 2025.
EU Regulation 536/2014 on clinical trials of medicinal products and the CTIS portal.
EU Regulation 2017/745 on medical devices and ISO 14155:2020.
French Jardé law and Public Health Code for research involving human participants.
GDPR and CNIL reference methodologies (MR-001, MR-003, MR-004).
CIOMS international ethical guidelines.

Selected training and areas of expertise:

ICH E6(R3) (2025) and auditor qualification (2013).
Information sheets and informed consent, vulnerable populations, pharmacogenetics.
Ethics, participant protection and confidentiality.
Pharmacovigilance and device vigilance: reporting obligations.
Electronic data capture (EDC) and IWRS.
CTCAE toxicity grading and RECIST criteria.
Source documents, investigational products and biological samples management.
First aid and CPR.

A scientific background (master’s degree in health nutrition, cell biology and physiology) plus in-depth knowledge of:

Documents for vendor qualification are available on request:

Tell me what you need: I reply within 2 business days with my availability and a first estimate.