Introduction
Pharmacovigilance (PV) is a cornerstone of patient safety in the pharmaceutical and healthcare industries. With increasing regulatory requirements and the need for efficient adverse event management, manual processes can no longer keep pace. At Vigisolvo, our PV Software Solutions are designed to automate and simplify the complex workflows of drug safety, including adverse event case processing, signal detection, and regulatory reporting. Using cutting-edge technologies like AI-driven pharmacovigilance, we ensure compliance, accuracy, and streamlined processes for pharmaceutical companies, biotech firms, CROs, and regulatory bodies worldwide.
Key Benefits of Vigisolvo's PV Software Solutions
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✔️ Automation of Case Processing
Reduce manual effort through intelligent automation.
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✔️ Regulatory Compliance
Meet global standards (FDA, EMA, ICH) effortlessly.
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✔️ AI-Powered Signal Detection
Identify and analyze safety signals with precision.
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✔️ Time-Saving Reporting Tools
Automate PSURs, DSURs, and PBRERs for faster submissions.
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✔️ Centralized Drug Safety Data
Access real-time dashboards for decision-making.
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✔️ Scalable and Flexible Solutions
Custom-built to meet the needs of small, mid, and large organizations.
Core Features of Our PV Software Solutions
Case Intake and
Management Automation
Our platform streamlines the adverse event management lifecycle – from case intake to reporting.
- ✔️ Automated case processing workflows
- ✔️ Seamless integration with EHR systems
- ✔️ AI-based data validation to minimize errors
Signal Detection and
Analysis
Identify and assess safety signals proactively with AI-driven signal detection software.
- ✔️ Advanced machine learning algorithms
- ✔️ Customizable signal thresholds
- ✔️ Real-time signal reports for faster decision-making
Regulatory Reporting
Tools
Simplify compliance with automated generation of periodic safety reports.
- ✔️ DSUR (Development Safety Update Reports)
- ✔️ PBRER (Periodic Benefit-Risk Evaluation Reports)
- ✔️ PSUR (Periodic Safety Update Reports)
Safety Data
Analytics
Leverage advanced analytics to derive actionable insights from safety data.
- ✔️ Data visualization tools for better insights
- ✔️ Predictive analytics for risk management
- ✔️ Custom reporting capabilities
Real-Time Data
Monitoring
Monitor safety data in real-time to ensure swift response to safety issues.
- ✔️ Continuous data stream monitoring
- ✔️ Alerts for significant safety events
- ✔️ Integration with existing surveillance systems
Why Choose Vigisolvo?
At Vigisolvo, we combine technology, expertise, and flexibility to deliver best-in-class PV Software Solutions
Client Success Story
Vigisolvo’s PV Software Solutions transformed our pharmacovigilance workflows. Case processing time reduced by 40%, and compliance with regulatory submissions improved significantly. A game-changer for our drug safety operations
— Director of Drug Safety, Leading Pharma Company
Frequently Asked Questions
What is PV software?
PV software automates and streamlines pharmacovigilance activities, including adverse event management, safety reporting, and signal detection.
How does Vigisolvo ensure regulatory compliance?
Our software aligns with global pharmacovigilance standards like FDA, EMA, and ICH, automating submissions such as PSURs and DSURs.
Can your PV software integrate with existing systems?
Yes, our solutions are fully compatible with EHRs, safety databases, and other clinical systems.
What makes Vigisolvo's software AI-driven?
We leverage machine learning and artificial intelligence for signal detection, case validation, and predictive analytics to enhance decision-making.
Ready to Streamline Your Pharmacovigilance Processes?
Contact us today for a free demo or to discuss how Vigisolvo’s PV Software Solutions can transform your drug safety operations.