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 We propose and
carry out in accordance with international regulations (ICH, CRF-21), and GCP,
audits concerning organisation, data management and quality of study data.
The Quality
Manager is responsible for mobilising sufficient internal and external
resources, that are necessary to assure the structure of the audit, of the
service or the study in progress.
The audit report,
presents our recommendations and allows for the preparation for an eventual
audit by public institutions (FDA, Afssaps, ...) or by participating
industrials..
Our expertise and
experience in medical information systems (SI) allows us to evaluation SIs and
data bases for health care networks, trials, registers and observatories.
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