Pharmacovigilance Adverse Event Management Platform
PVantage is an innovative platform, powered by Oracle’s Argus Safety Suite, that allows drug safety teams to collect, review and report adverse drug reactions and other safety events during a clinical trial or post market surveillance. This adverse event reporting tool goes beyond the collection and reporting and provides the ability to analyze and visualize patient, program, drug class information for greater control and oversight of your safety data.
PVantage is a cloud-based solution that allows Sponsors to elect the degree of automation of all workflows for case intake, case processing assessment, and submission. A dedicated, virtual, managed environment provides Sponsors with an always up-to-date platform and assures compliance with ever-changing global PV regulations.
Key benefits of PVantage include:
- Automated narratives and query letter generation setup
- Reduced operational complexity and cost through sharing the infrastructure burden
- Automated standard reporting configurations to handle submissions to sponsor and regulatory stakeholders
- Seamless integration with clinical data systems including Oracle’s Argus, IBM Clinical and Axway E2B(R3) for electronic submissions to global health authority gateways
- Off-the-shelf advantages of custom reporting, including monthly KPI reporting, cumulative safety listings, and compliance reporting
- Customizable data visualization layer that allows for near real-time data enquiry and more informed decisions
- Strong data protections and data privacy compliance
- Dictionary Management (MedDRA and WHO)
- Seamless migration methodology and data quality assurance for an easy transition to PVantage
With PVantage, Sponsors gain an accelerated technological advantage with greater visualization and efficient reporting of safety data.
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Quality & Compliance
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