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Quality Assurance.
ERGOMED’s quality assurance (QA) is based on industry standard
SOPs including project management, monitoring, site management,
pharmacovigilance and phase I/IIa unit SOPs. QA within ERGOMED
is an ongoing activity applying to processes and specific studies.
QA group and processes are supervised by an independently owned
and managed UK company “Country Consultancy Ltd”, directed
by Nigel J. Dent, FRQA,
(http://www.countryconsultancyltd.co.uk) ensuring objective assessments and
independent audits.
ERGOMED offers QA services covering the following areas:
• Site audit
• Review of monitoring plans and project plans
• Master file audit
• Central lab audit
• Pharmacy audit
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