Pharmacovigilance
Minimizing adverse event management in a dynamic case processing workflow
Today's Pharma companies face growing complexity in global regulations and increases in adverse event volume, all while adapting to changing technology of data sourcing.
This requires a different approach to Pharmacovigilance management; one which is automated, intelligent and outcome driven to improve product quality, optimize treatment plans, reduce costs, and improve patient safety.
Safety Challenges
Global AE case volumes are increasing 15-20% annually and doubling in the next few years, leading to increased workload and more potential errors.
Our Solution
A new way to manage Pharmacovigilance with a fully-integrated, custom, end-to-end PV Software Application.
PV-SECURE™
Safety Case
Intake
Safety Case
Processing
Reportabilty-
Submission Insights
PV-SECURE™
A solution that ensures your data is clean, healthy, and uninterrupted at every stage.
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Adverse events case processing (AECP) leveraging automated and configurable business rules
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Multi-channel entry of safety case data
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Delivered in a 21 CFR Part-11 compliant, validated environment to meet increasingly complex regulatory environment
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Automated ingestion via standard E2B format
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API (REST, SOAP, Custom) automated ingestion
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Batch imports / OCR capabilities to reduce manual data entry
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Customizable context-based dynamic workflows to enhance performance
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Portal access to give visibility to Investigators and sponsors into safety profile of an investigational product throughout its lifecycle
PV-SECURE™
Get management insights on demand
Automated reporting for complex global regulations, increased AE event volume and rapidly growing sources of data including:
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Configurable reporting rules by country and recipient
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Reporting to Regulatory Agencies, Competent Authorities, Ethics Committees and Clinical Trial Investigators
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Auto-generated templates and Cover Letters
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Multi-channel package delivery: secure email, fax, portals, courier and hand delivery
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Automated tracking and field-level auditing
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Monitoring based on SLAs with escalation
Automated, intelligent workflow, to improve the pharmacovigilance function
Corporate Headquarters
855-751-5527