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Audit
FOVEA follows a global approach which combines our technical competence (conception of studies, Monitoring, Data Management, Statistics, Medical Writing) with our proven expertise of Quality Management.
The services that we offer are based on two central themes:
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Audits | |
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Consultancy in Quality Management |
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Audits |
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Audits of phases IIb to IV clinical trials during every single stage of the process | |
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Systems Audits (ISO 9000 Quality System, procedures) | |
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Service providers Audits |
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Consultancy in Quality Management |
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Implementation of a quality procedure: | |
| . assistance with methods recognition and analysis | ||
| . assistance in determining, in relation to quality, the guiding elements in the methods | ||
| . drawing up the appropriate documentation in relation to quality | ||
| . implementation of Quality Management tools |
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Guidance and assistance all along the Certification procedure under the ISO 9000 standards: | |
| . assistance with the conception of the quality manual | ||
| . assistance with procedures implementation | ||
| . audit prior to certification |
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Training: | |
| . heightening staff sensibility to Quality | ||
| . practical tutorial on the ISO 9000 standards | ||
| . internal Quality Auditors |
ON-LINE STUDIES