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Safety Surveillance using Oracle AERS
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Technology and Experience
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Synteract's Safety Surveillance Department was formed to assist pharmaceutical companies in effectively managing a product's
benefits and risks. In today's competitive market, companies need continuous access to their product's safety data and an
experienced team that understands how this data affects regulatory and product safety requirements. A solid knowledgeable Safety
Surveillance team is a necessity.
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Our team of experienced pharmacovigilance experts consists of a PharmD, RNs, and MD consultants. Synteract employs
Oracle® AERS
to perform safety surveillance, reporting and management, thus allowing Synteract to offer its clients live access to data,
management, and reporting tools via a standard web browser. Oracle®AERS is a fully validated, Synteract hosted solution.
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Safety Surveillance Services
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- Receipt/Review/Dissemination/Entry of SAE
- Narratives
- Safety Monitoring and Assessment
- Regulatory Submission and Reporting
- Safety Database Management
- Reconciliation with CRF
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