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Pharmacovigilance, Medical Device Safety, and Safety Management

Product safety is paramount in all stages of the development lifecycle. In addition to traditional pharmacovigilance and medical device safety reporting, we provide comprehensive support for Data & Safety Monitoring Board (DSMB) and Clinical Event/Endpoint Committee (CEC) selection and management during the clinical trial. Our experienced team has current knowledge on safety regulations and clinical safety data, access and experience with the requisite data systems, and established relationships with the regulatory and provider stakeholders to conduct an efficient, balanced and thorough process. Our pharmacovigilance department compliments our Safety & Epidemiology work with the FDA Sentinel Programs.