Aurélie Viriat

- Writing of clinical study reports (oncology, depression, autism, heart failure, hemostasis, arterial hypertension), including pediatric reports (depression, autism)

- Writing of clinical study protocols (oncology and obesity)

- Writing of informed consent forms (oncology and epilepsy)

- Writing of the clinical study sections of dossiers for the Transparency Commission (oncology)

- Updating investigator brochures, clinical study protocols

- Quality control of documents: clinical study protocols, scientific articles

- Assistance and support in writing scientific articles for peer-reviewed journals (anesthesia, oncology, and pediatric gastroenterology)

- Writing articles in the field of oncology for the Web

- Writing a state-of-the-art review in the context of a clinical evaluation report for a medical device in orthopedics (shoulder prosthesis), in English and French, according to Meddev 2.7/1 rev 4.

- Writing of course materials (anatomy/biology)

- Writing of training materials (detailed plan) (cardiovascular)

For the products under my responsibility in the fields of oncology and cardiovascular:

- Writing of reports on safety data from clinical trials:

• ongoing studies, blinded or unblinded depending on the studies

• end of study, using pooled data from multiple studies

- Participation in "Safety Team" meetings, bringing together various stakeholders responsible for product safety

- Participation in writing sections 6 (Estimated Cumulative Exposure), 7.3 (Cumulative Summary Tabulation of SAE), 8 (Significant Findings from Clinical Trials during the Reporting Period) and 10 (Other Clinical Trial/Study Safety Information) of DSURs (Development Safety Update Report) and review of other sections.

- Review of PSURs (Periodic Safety Update Report) and Risk Management Plans.

- Writing of clinical study reports in several therapeutic areas: oncology, arterial hypertension, heart failure, depression, rheumatology.

- Participation in clinical study data review meetings before unblinding.

- Review of protocols, statistical analysis plans.