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The QA group was originally established at CTMS as an internal resource to maintain quality and to work proactively to identify processes that could be further improved. With time and experience, Clinical Quality Assurance emerged as an available service by Sponsor request to assist with QA needs. Our auditors are registered nurses with pharmaceutical research monitoring experience and QA training.
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Specialization in U.S. Good Clinical Practice (GCP) audits
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Routine or for-cause audits at investigator sites
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Pre-FDA inspection evaluation
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Site-related compliance assessment encompassing protocols, amendments, source documents/medical records, Case Report Forms, regulatory files, drug storage and accountability
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Sponsor/CRO assessment
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