Pharmacovigilance
Materiovigilance
Cosmetovigilance
Nutrivigilance
Intelligence
Pharmacovigilance, Medical Device Vigilance, Cosmetovigilance, Nutrivigilance, Veterinary Vigilance
Intelligence Pharmacovigilance, Medical Device Vigilance, Cosmetovigilance, Nutrivigilance, Veterinary Vigilance
What we do.
vGenix Ai is a Pharmacovigilance Intelligence Platform which helps the Life Science companies to automate ICSR Processing, Signal Management, Aggregate Reporting, Literature Discovery through our most sophisticated technologies in a more efficient and cost effective way.
How we do.
We are using Gen AI, Machine Learning, Natural Language Processing (NLP), Robotic Process Automation (RPA) and Agentic AI workflow to extract and enrich all the necessary information using our pretrained out of the box models.
Why you choose us.
We are customer centric and tailored the solution according to the customer requirements. We ensure faster onboarding time and reduce the time to production. Our solutions are highly configurable and easy to adopt ever changing client requirements. Cost effectiveness is our primary motto.
We Do Omnivigilance
Automation Made Easy
ICSR Automation
ICSR processing automation uses AI to streamline the collection, processing, and analysis of adverse event reports in pharmacovigilance. This tech-driven approach enhances efficiency, accuracy, and speed in identifying potential safety issues with pharmaceutical products.
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Omnivigilance
Our solution can process ICSR for Medicinal Products, Medical Devices, Cosmetics and Nutritional Products. -
Multilingul Support
Our Technology can handle multiple languages and multiple geograhies. -
Automated Data Extraction
AI-powered algorithms extract relevant information from various sources, such as PDFs, emails, and forms, reducing manual data entry errors. -
Case Assessment and Triage
AI-driven systems assess the validity and seriousness of ICSRs, enabling prioritization of cases requiring immediate attention.
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Standardization and Coding
AI applies standardized medical coding (e.g., MedDRA) and classifies cases according to predefined criteria, ensuring consistency and accuracy. -
Regulatory Reporting
The platform can generate E2B R2/R3 XML formats to submit various dafety databases and various geographies. -
Regulatory Compliance
AI-powered ICSR automation ensures compliance with global regulatory requirements, such as those set by the FDA, EMA, and ICH.
Signal Management Automation
Signal Management automation in pharmacovigilance utilizes AI to identify, validate, and prioritize potential safety signals from large datasets, enabling proactive risk management and informed decision-making.
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Signal Detection
AI-powered algorithms analyze vast amounts of data from various sources, including ICSRs, literature, and social media, to identify potential safety signals. -
Data Mining
AI-driven data mining techniques, such as statistical analysis and machine learning, uncover hidden patterns and relationships in data. -
Signal Validation
AI-assisted signal validation processes evaluate the strength of evidence, clinical relevance, and potential impact on patient safety.
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Signal Prioritization
AI-driven prioritization frameworks assess signal severity, frequency, and causality, enabling focus on high-priority signals. -
Automated Signal Management
AI automates signal management workflows, streamlining the signal detection, validation, and prioritization process. -
Enhanced Sensitivity and Specificity
AI-powered signal detection improves sensitivity and specificity, reducing false positives and false negatives.
Aggregate Reporting Automation
Aggregate Reporting automation in pharmacovigilance utilizes AI to streamline the collection, analysis, and submission of aggregate safety data, enabling efficient and accurate reporting to regulatory agencies.
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Automated Data Aggregation
AI-powered algorithms collect and aggregate safety data from various sources, including ICSRs, clinical trials, and post-marketing surveillance. -
Data Analysis and Signal Detection
AI-driven analytics identify trends, patterns, and potential safety signals in aggregate data, supporting informed decision-making. -
Report Generation
AI automates the generation of aggregate reports, such as PSURs (Periodic Safety Update Reports) and PBRERs (Periodic Benefit-Risk Evaluation Reports).
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Standardization and Formatting
AI ensures compliance with regulatory requirements and guidelines, applying standardized formats and templates for aggregate reports. -
Data Quality and Integrity
AI-powered data validation and verification processes ensure the accuracy, completeness, and consistency of aggregate safety data. -
Regulatory Compliance
AI-driven aggregate reporting automation ensures compliance with global regulatory requirements, such as those set by the FDA, EMA, and ICH.
Literature Monitoring Automation
Automated Literature Monitoring: AI-powered algorithms search Global/Local literature databases, identifying relevant articles and publications related to specific products or compounds.
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Article Screening and Triage
AI-driven screening processes evaluate article relevance, prioritizing those requiring further review and assessment. -
Relevant Information Extraction
AI extracts relevant safety information from articles, including adverse events, product details, and study outcomes. -
Case Identification and Assessment
AI identifies potential cases and assesses their relevance and seriousness, supporting further evaluation and reporting.
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Standardized Review Process
AI ensures consistency and standardization in literature review processes, applying predefined criteria and guidelines. -
Improved Efficiency and Productivity
Automation minimizes manual processing time, allowing pharmacovigilance teams to focus on higher-value tasks and improving overall productivity. -
Regulatory Compliance
AI-driven literature search and review automation ensures compliance with global regulatory requirements and guidelines.
One Platform For Omnivigilance
Advanced AI Technologies
Combines sophisticated AI, Machine Learning, Deep Learning, NLP, and Rule-based Inference to deliver unparalleled processing power.
Configurable Workflows
Customizable workflows turbocharge critical processes like ICSR processing, Signal Management, Aggregate Reporting and Literature Monitoring
Multi-Document Processing
Effortlessly handles diverse document types, transforming unstructured data into actionable business insights.
Scalable Solution
Adapts to businesses of all sizes, from startups to enterprises, with flexible deployment options.
User-Friendly Interface
Intuitive platform design requires minimal training, enabling rapid adoption across your organization.
Seamless Integrations
Powerful API connections allow easy integration with your existing systems and workflows.
Proven Efficiency Gains
Reduces manual labor by 90%, boosts accuracy, and delivers up to 50% cost savings while accelerating operations.
Actionable Insights
Transforms raw data into intelligent, business-driving information that gives you a competitive edge.
Document Intelligence
Document Intelligence in Pharmacovigilance leverages AI to understand, classify, parse information from diverse documents, such as ICSRs, literature articles, and clinical study reports. AI-powered algorithms automate layout analysis, table data extraction and validation, improving accuracy and efficiency.
Clinical Intelligence
We are using Gen AI, Machine Learning, Natural Language Processing (NLP), Robotic Process Automation (RPA) and Agentic AI workflow to extract and enrich all the necessary information using our pretrained out of the box models.
Process Intelligence
We are customer centric and tailored the solution according to the customer requirements. We ensure faster onboarding time and reduce the time to production. Our solutions are highly configurable and easy to adopt ever changing client requirements. Cost effectiveness is our primary motto.
Key Technologies
Our platform utilizes a range of cutting-edge technologies, including:
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Artificial Intelligence (AI):
Our platform uses AI to analyze documents, identify patterns, and make predictions.
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Machine Learning (ML):
Our ML algorithms continuously learn and improve document processing accuracy.
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Agentic AI:
Agentic AI enables autonomous decision-making and action-taking, further streamlining document processing workflows.
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Large Language Models (LLMs):
LLMs provide advanced language understanding and generation capabilities, enhancing document analysis and processing.
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Optical Character Recognition (OCR):
Our advanced OCR technology extracts text from scanned or photographed documents.
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Natural Language Processing (NLP):
Our NLP capabilities understand document context and extract relevant information.
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Robotic Process Automation (RPA):
RPA automates repetitive tasks, reducing manual effort and increasing efficiency.
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Rule-Based Systems:
Using predefined rules to automate document classification, data extraction, and validation, based on specific document structures, content, or metadata.
Businesses can do extraordinary things with vGenix Ai
Your enterprise data is safe within your control
End-to-End Encryption
Your data is encrypted at all stages for maximum protection.
24/7 Monitoring & 99.9% Uptime
Guaranteed high availability with round-the-clock monitoring.
Audit Logs & Portal
Perform and access comprehensive audit logs in the Audit Portal.
Complete Data Control
Maintain full control over your data and access permissions.
Multi-tenant and Multi-region Architecture
Designed to scale globally, supporting multi-tenant and multi-region data architectures for ultimate flexibility.
Regular Security Audits
Frequent assessments to identify and mitigate potential vulnerabilities.
Built on Trust. Secured for Pharma.
Our platform is rigorously built to meet HIPAA standards, ensuring that all Protected Health Information (PHI) is handled with the highest level of security, confidentiality, and regulatory compliance.
SOC2 Certified
Our platform meets the highest standards for data security, availability, and confidentiality.
HIPAA Compliant
We adhere to strict regulations to ensure the privacy and security of Protected Health Information (PHI).
Ready to streamline your Pharmacovigilance Operation?
Start your free trial today