Glenda Guest is Vice President of Norwich Clinical Research Associates Ltd (NCRA). This full-service clinical CRO in upstate NY consults on study development, monitoring and analysis; clinical and data-management-department development; regulatory consulting; SOP consulting; GCP and clinical regulatory training/auditing services. NCRA has performed a number of FDA mandated third-party audits for companies against which an integrity hold has been applied – an experience that has allowed Ms. Guest to develop a solid understanding of CDRH expectations.
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