Individual Case Safety Report Automation
Smarter Case Processing, Trusted Outcomes
ICSR Processing Features
ICSR Processing Features
- Multi-Channel ICSR Intake
- Multi-Lingual Case Processing
- Multi-Format Document Handling
- Automated Document Classification
- AI-Enabled Duplicate Detection & Reconciliation
- Automated Case Creation & Triage
- AI-Based Safety Data Extraction
- Automated Seriousness Classification
- Automated MedDRA Mapping & Review
- AI-Powered Causality Analysis
- AI-Based Narrative Generation
- AI-Powered Quality Assessment
- E2B R3 Submission-Ready Output
- Configurable E2B R3 Templates
- Configurable Rule Validation
Platform Features
- Full-Featured Enterprise Platform
- Role-Based Access
- Real-Time Dashboards
- Human-in-the-Loop Support
- Automated/Manual Case Allocation & Management
- Case Lifecycle Management
- Collaborative/Review Support
- Knowledge Management & Data Organization
- System Monitoring, Alerts & Notifications
- Case Archive & Audit-Ready Restore
- Transparent AI Reasoning & Source Traceability
- Data Analysis & Reporting
- Highly Scalable
- AI-Powered Configurable Decision Engine
- Secure & Multi-Tenant SaaS Infrastructure
Any Data. Any Formats. Any Time.
Any Data
Handles diversed healthcare data types, accepts structured, semi-structured and unstructured data.
Any Formats
Processes data in various formats. Supports text, image, PDFs and other formats.
Any Time
Provides real time data processing. Supports continuous data ingestion and analysis.
Document Ingestion
vGenix Ai ingests documents from various sources for further processing. The sources are not limited to Direct uploading, SFTP, API, Emails and other channels. Custom ingestions are also supported.
Document File Types
We are supporting variety of document file types, not limited to the following.
- Text
- Word, Excel, CSV
- PDF, Scanned PDF
- Images
- Email Contents
- HTML, XML
- HL7 and other medical standards
- All E2B standard formats
Input Data Types
Pharmacovigilance systems receive data from a wide variety of document types—each with its own structure, purpose, and insights. Our platform is designed to handle them all with precision. Structured or unstructured — we make every word count. From scanned pages to real-time XML — nothing gets missed.
- CIOMS 1
- CIOMS 4
- MedWatch
- Various Types of AER forms
- IRMS
- EVWEB
- Submissions Free Text
- E2B XML Formats
- AYUSH Forms MAH, CRO
- Company Specific Forms
- Narrative PDFs
- Email Content
- Literatures
Document Pre-processors
Document Converters
We prioritize the use of Artificial Intelligence (AI) in every aspect of our products and services.
Document Layout Analyzer
Streamlined workflows through complete automation, reducing errors and increasing productivity without any manual touch.
Document Splitters
Accelerating the client onboarding process through streamlined workflows, automation, and standardized procedures.
Header Footer Removal
High-accuracy guarantee: 95% and above precision in every deliverable.
Spell Checkers
Our cost-effective solution streamlines processes, reduces costs, boosts efficiency, and is tailored to your specific needs.
NLP Pre-processing Techniques
Our approach lets you customize our solutions to fit your unique customer requirements.
Document Classification
Our Intelligent Document Classification system leverages advanced machine learning to accurately categorize incoming ICSR forms into its corresponding classes to ensure seamless processing without any manual effort. Various different classification models can be built based on our cutting edge technology.
Features
- No manual touch
- 100% Classification Accuracy
- Works for all standard data sources out of the box
- Quickly adopt the new formats easily
- Trainable with few examples
- Hybrid approach
- Faster
- Triage and Processing
- Accurate Document Routing
- Fully Automated
Information Extraction
Our AI-powered Extraction engine reads, understands, and transforms raw pharmacovigilance documents into structured, compliant data—ready for downstream processing and reporting. We are not only extract the data, we standardize, contextualize and validate it for high accuracy.
-
General Information
- Source of report (e.g., MAH, CRO, Affiliate).
- Report type (spontaneous, literature, solicited).
- Regulatory authority, submission details.
- Reporter qualification (HCP, Consumer).
-
Patient Information
- Age, gender, weight, ethnicity.
- Patient identifiers (initials, ID).
- Medical history, relevant tests/labs.
-
Product Information
- Suspect and concomitant drugs.
- Dosage, route, frequency, therapy dates.
- Indication for use, batch/lot numbers.
-
Event Information
- Adverse event terms and descriptions.
- Seriousness criteria and outcome.
- Event onset date, duration, resolution.
- Causality and dechallenge/rechallenge results.
MedDRA/WHO-DD Term Mapping
MedDRA/WHO-DD Term Mapping plays a crucial role in pharmacovigilance by ensuring the accurate and standardized classification of Adverse Drug Reactions (ADRs) and other medical events. MedDRA/WHO-DD Term Mapping provides the structured framework for recording and analyzing ADRs. This enables, Facilitating Data Analysis, Identification of Safety Signals, Regulatory Reporting Promoting Data Sharing.
- Facilitating Data Analysis
- Identification of Safety Signals
- Regulatory Reporting
- Promoting Data Sharing Coding Systems:
-
LLT (Lowest Level Term)
- The most specific MedDRA term.
-
PT (Preferred Term)
- Standardized term used for analysis and reporting.
WHO-DD (World Health Organization Drug Dictionary)
- Used for coding adverse drug reactions and other medical conditions in pharmacovigilance, particularly in the context of WHO activities.
MedDRA (Medical Dictionary for Regulatory Activities) A standardized hierarchical system for classifying medical conditions, adverse events, and other pharma related terms, used globally for regulatory reporting and data analysis in healthcare.
Narrative Summary
A Narrative is a brief summary of specific events experienced by patients, during the course of a clinical trial. Narrative writing involves multiple activities such as generation of patient profiles, review of data sources, and identification of events for which narratives are required.
- Supports both Extractive and Descriptive Summaries
- Template based Narrative summary
- AI Based Narrative summary
- Highly Configurable
- Supports various templates for various cases and regulatories
E2B R3 XML Generation
E2B(R3) XML files serve as a standardized format for transmitting safety information, allowing for the efficient and accurate exchange of ICSRs. vGenix Ai offer features for generating and managing E2B(R3) XML files.
- Data Mapping: vGenix Ai maps case data to create E2B(R3) XML files, ensuring compliance with the standard.
- Regional Differences: While the E2B(R3) standard provides a core structure, regional variations and additional data elements may be included, as per the requirements of specific regulatory agencies like EMA and FDA vGenix Ai handles all the regional and custom mappings.
- Testing and Validation: Before submitting E2B(R3) files to regulatory agencies, it's crucial to test and validate them to ensure compliance with the E2B(R3) standard and regional requirement.
- Batch Processing: Our platform supports batch export of E2B(R3) reports, allowing multiple ICSRs to be included in a single XML file.
- Data Integrity: When generating E2B(R3) XML files, we ensure the accuracy and completeness of the data, paying attention to mandatory elements and data coding against standard terminologies.
Compliance First Platform
The Compliance First Platform in pharmacovigilance embeds regulatory adherence into every process to safeguard patient safety. It delivers transparent, auditable workflows that ensure trusted oversight of drug safety monitoring.
Audit Ready Software. Every action is recorded as per the audit requirements and always ready for auditing.
All Major Regulatory Compilance. Multi-Country, Multi-Regulatory support. Periodic updates of the guidelines.
Secure Data Processing & Storage. SSH, Database Encryption, Multi-Tenant, HIPAA, SOC2.
21 CFR Part 11& EU GvP Compliant. The platform is assuring the reliability of electronically produced records and signatures.
Seamless Integrations. Smarter Safety.
Seamlessly connect with leading pharmacovigilance systems and data formats
Oracle Argus
ARISg
Veeva Vault
Excel & CSV
E2B R3 XML
Databases
Deployment Strategies
Platform
- Our own Platform.
- Our own Maintenance.
APIs
- Cloud as per the Client geographic preference.
- Our own Maintenance.
On-Prem
- Client Infrastructure.
- Our own Maintenance.
Cloud Providers
Supports all the cloud providers.
Scalability
Can be scaled at anytime based on the load. Load balancers and fail overs will be provided.
Your Security is Our Priority
Security
- Data will be secured over the channel (SSL).
- Encrypted Database.
- All regulatory standard compliance are strictly followed.
Support
- Multi-Tier Support.
- 24/7 Support.
- Fast Response and Resolutions.
Benefits
AI First Approach
We prioritize the use of Artificial Intelligence (AI) in every aspect of our products and services.
End-To-End Automation
Streamlined workflows through complete automation, reducing errors and increasing productivity without any manual touch.
Faster Onboarding
Accelerating the client onboarding process through streamlined workflows, automation, and standardized procedures.
Accuracy Guarantee
High-accuracy guarantee: 95% and above precision in every deliverable.
Cost Effective
Our cost-effective solution streamlines processes, reduces costs, boosts efficiency, and is tailored to your specific needs.
Build For Your Needs
Our approach lets you customize our solutions to fit your unique customer requirements.
Ready to streamline your Pharma Operation?
Start your free trial today