Maïté de Richemond - Amy

Responsible for the independent preparation, review & approval of country related submission packages in accordance with ICH, GCP

Develop and finalize Master and Country Specific Information Sheets/ Informed Consent Forms

Responsible for the independent preparation, review and approval of site level critical documents for Investigational Product release within specific timelines and quality standards.

Perform site contract negociation.

Phase II: Diabetis
Multicenter, Double-blind, Controlled, Randomized
Patients: adults with diabetic kydney disease
Responsibilities: initiation and monitoring of 11 sites
e-CRF: inform, IVRS, central lab


Phase III: Metabolism
Multicenter, Double-Blind, Placebo Controlled, Randomized
Patients: Children with Phenylketonuria
Responsibilities: initiation and monitoring 1 site
e-CRF: inform, Icophone, central lab


Phase III: Metabolism
Multicenter, Double-Blind, Placebo Controlled, Randomized Patients: Adults with Phenylketonuria
Responsibilities: feasability 3 sites

Phase II: Oncology
Single-Arm Multicenter Dose Evaluation
Patients: Pediatric and Adolescent with Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
Responsibilities: feasability 5 sites

Phase III: Cardiology
Multicenter, Randomized, Double-Blind
Patients: Acute Coronary Syndrome
Responsibilities: Monitoring of 7 sites and back-up CRA on 36 French sites.
e-CRF: inform, IVRS, central lab

International Clinical Coordination:
Phase III Oncology trial (Coordination of the monitoring in 9 French centres with a Spanish project manager)
Phase III Ophtalmologic trial (Coordination of the monitoring in 2 French and 1 Switzerland centres with Czech project manager)
Correction of protocol, Drafting of patient CRF, information consent form

Monitoring on site & Audit:
Pre-study visits, Investigator meetings, Initiation visits and Monitoring visits (e-CRFs and paper CRF) of epidemiologic and clinical trials:
Phase III Orthopaedics trial (2 French and 1 Belgium centres)
Phase III Cardiological trial (5 French centres)
Phase III Oncology clinical trial (20 French centres)
Phase II Neurological trial (2 French centres)
Phase III Neurological trial (5 French centres)
Phase IV Gastroenterology
CRF Completion:
Phase III Oncology clinical trial (6 French centres)

Training in the ADDS training centre: CRA profession

Research of gene involved in the etiology of the Amyotrophic Lateral Sclerosis
Studies of Streptococcus agalactiae virulence
In charge of education of Genetics in Science University

Biology and Geology

Sale of consumables and equipments intended for the laboratories of microbiology

Studies of Salmonella enteritidis virulence
In charge of education in technical university - Tours - Biochemistry, Genetics & Bacteriology