All studies performed by IFE Baltic have to pass our quality control
and will then be audited by a
quality assurance group
according to FDA and ICH-GCP guidelines,
following IFE's Baltic or sponsor's SOPs
in accordance with the most up-to-date guidelines and regulatory requirements as well as with regional legislation.
Independent on-site audits
are based on audit protocol and SOP's, including source data verification.
Training and certification of investigators
is performed in workshops. GCP-regulations and study protocol are trained, test and certification included.
System and expert audits
are implemented, quality assurance systems are checked.
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