Quality Standards

NON-CLINICAL

GLP certified since Nov 2000, ANSM (French Medicines Agency)

AAALAC Accreditation on going

 

CLINICAL

GCP & ICH guidelines

Clinical Pharmacology Units certified by ARS (authorizations 05001M, 10010M)

ANVISA certification

FDA inspection in Ph II study

 

BIOANALYSIS LAB

FDA inspections

AGES (Austria)

SCC (Canada)

 

PHARMACY

GMP authorization for supplying, packaging, labelling and stocking (ARS)

Authorizations granted: Rennes 05001M

           

LABORATORY

GBEA standard (French law)

Certified Cofrac (French Accreditation Committee) according to NF EN ISO 15189

 

BIOMETRICS

Medidata RAVE

CDISC SDTM Implementation Guide (V 3.1.2)

Amendment 1 to Study Data Tabulation Model (SDTM) V1.2

CDISC ADaM for Analysis Datasets

ANVISA certification