Let's Talk

Pharmacovigilance Automation for Life Sciences

RegX Safety & Pharmacovigilance helps life sciences teams manage adverse event intake, case triage, medical review, narrative generation, medical coding, ICSR and SUSAR support, FAERS signal insights, literature monitoring, E2B XML generation, audit trails, connected CAPA references, APIs, user access, and operational dashboards.

 
 
 
Request a Demo

From Manual Tracking to Connected Pharmacovigilance Operations

PV teams often work across separate systems for adverse event intake, coding, literature review, signal monitoring, reporting outputs, and compliance records. This creates delays, duplicated effort, limited visibility, and inconsistent records. RegX brings these activities into one structured workspace, helping teams process work faster, monitor risks clearly, and maintain operational control.

 
 
 
Regulatory Automation

Manual Case Handling

Streamline adverse event intake, triage, follow-up, medical review, narrative generation, submission actions, and lifecycle tracking.

Limited Signal Visibility

Monitor safety patterns using FAERS insights, prioritization, risk evaluation, trend analysis, product views, and confidence indicators.

Scattered Literature Review

Track article findings, comments, highlights, reconciliation, product mapping, and searchable knowledge in one place.

Complex Case Documentation

Support medical coding, case narratives, structured records, case-level outputs, and E2B XML generation.

Limited Operational Control

Use dashboards, audit trails, activity logs, source controls, admin configuration, APIs, notifications, and role-based access.

Everything PV Teams Need to Manage Cases, Signals, Sources, Outputs, and Oversight

Safety Case Management

Manage adverse event cases from intake through review, follow-up, submission, documentation, and lifecycle tracking.

  • Adverse Event Processing
  • Case Intake & Triage
  • ICSR Case Support
  • SUSAR Case Support
  • Follow-Up Case Support
  • Medical Review Support
  • Narrative Generation
  • Case Submit Action
  • Case Lifecycle Management
  • Case Narrative Document Generation

Identify, prioritize, and review signals across products, cases, literature, FAERS data, and other sources.

  • Signal Detection
  • Signal Prioritization
  • Risk Evaluation
  • Trend Analysis
  • FAERS Signal Library
  • FAERS Signal Detail Pages
  • Product Safety Insights
  • Safety Pattern Review
  • Confidence Indicators

Configure and manage external sources that support literature monitoring, review, and signal evaluation.

  • PubMed Source Support
  • Europe PMC Source Support
  • ClinicalTrials.gov Source Support
  • OpenFDA / FAERS Support
  • Custom Source Configuration
  • Source Active / Inactive Toggle
  • Source Connection Testing
  • Source File Upload
  • Automated Search History
  • Scheduled Literature Monitoring

Generate structured case-level records and outputs to support PV documentation activities.

  • E2B XML Generation
  • Case Narrative PDF Generation
  • Case-Level Output Support
  • Regulatory Case Output Support
  • Structured Case Records

Centralize case history, literature findings, signal trends, article review activity, and searchable PV knowledge.

  • Safety Data Repository
  • Case History
  • Literature Findings
  • Article Highlights
  • Article Comments
  • Article Reconciliation
  • Signal Trends
  • Searchable Knowledge Base
  • Safety Relationship View
  • Knowledge Graph API

Connect PV workflows with related systems, external applications, and operational data flows.

  • Connected Sign-In Support
  • Role Mapping
  • Connected CAPA Support
  • Notification Sync
  • Case Data Sharing Support
  • Cases API for External Use
  • Knowledge Graph API
  • Admin Configuration Support
Medical Coding Support

Support structured case records with adverse event and drug coding assistance.

  • MedDRA Lookup
  • WHO-DD Lookup
  • Medical Coding Suggestions
  • Adverse Event Term Mapping
  • Reaction Coding
  • Expectedness Assessment

Monitor literature and intelligence sources to identify relevant updates, risks, and product-related findings.

  • Literature Monitoring
  • Safety Intelligence
  • Knowledge Management
  • Search & Analytics
  • Literature Review Support
  • Article Highlights
  • Article Comments
  • Article Reconciliation
  • Product Article Mapping
  • Product Creation from Literature Review

Use assisted review capabilities to accelerate signal review, literature evaluation, and case documentation.

  • Assisted Signal Extraction
  • Source Result Review
  • Search Expansion Support
  • Product Safety Insights
  • Narrative Support
  • Safety Data Review
  • Confidence Indicators

Maintain oversight with audit trails, activity tracking, notifications, access controls, and operational dashboards.

  • Audit Trails
  • Activity Logs
  • Compliance Visibility
  • CTOPS Case CAPA Detail Link
  • Connected CAPA Reference Support
  • Operational Dashboards
  • Notification Center
  • Access-Based Controls

Manage organization setup, users, roles, permissions, and controlled platform access.

  • Organization Management
  • Admin Configuration
  • User Invitation System
  • Email Verification
  • Password Reset
  • User Profile Management
  • Role-Based Access Control
  • Create/Edit Access
  • Approval Access
  • Full Access
  • Read-Only / Audit Access

From Intake to Controlled Monitoring

Intake

Capture adverse events, literature findings, case details, and related source information.

Triage

Classify cases, assess seriousness, prioritize activities, and manage case status.

Code

Apply MedDRA lookup, WHO-DD support, term mapping, reaction coding, and expectedness assessment.

Review

Support medical review, case validation, narrative review, follow-up assessment, and documentation checks.

Analyze

Review signal patterns, FAERS insights, literature findings, product trends, and confidence indicators.

Document

Generate case narratives, E2B XML, structured records, and case-level outputs.

Monitor

Track case status, signal trends, literature updates, source activity, audit logs, notifications, compliance activity, and dashboards.

A Clear Path from Adverse Event Intake to Monitored Case Status

Adverse Event Intake

Capture reporter details, patient information, product data, adverse event description, and source information.

Manage cases based on seriousness, expectedness, product context, and reporting need.

Store case details, coding data, narrative content, status, follow-up information, and lifecycle updates.

Prepare structured records, case narrative PDFs, and supporting documentation outputs.

Submit or mark the case through the available case submission action and maintain status visibility.

Case Intake & Triage

Classify the case, assess seriousness, identify follow-up needs, and confirm the case type.

Apply MedDRA and WHO-DD support to structure adverse event and product information.

Support reviewer assessment, validate case context, generate narratives, and maintain documentation history.

Generate E2B XML output for case-level regulatory reporting support.

Track follow-ups, signal relevance, audit history, dashboard activity, and case lifecycle status.

 

Stronger Control Across PV Operations, Documentation, and Compliance Visibility

Faster Case Processing

Improve intake, triage, adverse event processing, review, narrative generation, submission actions, and lifecycle tracking.

Better Coding Support

Use MedDRA lookup, WHO-DD lookup, term mapping, reaction coding, and expectedness assessment to improve documentation quality.

Clearer Case Documentation

Generate narratives, structured records, E2B XML outputs, and case-level documentation with better consistency.

Better Signal Visibility

Identify patterns earlier with FAERS views, prioritization, risk evaluation, trend analysis, and product insights.

Stronger Literature Oversight

Bring article review, comments, highlights, reconciliation, product mapping, search history, and analytics into one workspace.

Better Source Control

Manage source configuration, active/inactive status, connection testing, file upload, and scheduled monitoring.

Stronger Compliance Visibility

Maintain audit trails, activity logs, role-based access, notifications, CAPA references, and operational dashboards.

Better System Connectivity

Support external workflows with Cases API, Knowledge Graph API, role mapping, connected sign-in, notification sync, and admin controls.

Built for PV Operations, Medical Review, Quality, Administration, and Access-Based Users

Organization Admin

Manage organization setup, invitations, access levels, permissions, admin configuration, and platform controls.

System Administrator

Maintain system settings, user controls, source configuration, access governance, and operational administration.

Drug Safety Associate

Support intake, adverse event processing, follow-ups, documentation, literature review, submission support, and workflow execution.

Medical Reviewer

Review case details, assess medical accuracy, evaluate seriousness, validate narratives, and support safety decisions.

QA Auditor

Review audit trails, compliance records, activity logs, connected CAPA references, and process evidence.

Create/Edit Users

Create and update cases, products, literature records, source configurations, and operational content.

Approver Users

Approve assigned records and activities based on access permissions.

Full Access Users

Manage workflows, dashboards, reports, users, APIs, configuration, and available operational activities.

Read-Only / Audit Users

View records, dashboards, reports, audit evidence, source activity, and compliance information without editing controlled data.

Strengthen Safety & Pharmacovigilance with RegX

Manage adverse event cases, ICSR and SUSAR support, medical review, narrative generation, MedDRA and WHO-DD coding, FAERS insights, literature surveillance, source configuration, E2B XML generation, audit trails, connected CAPA references, APIs, and operational dashboards in one connected PV platform.

 
 
 
 
 
Schedule A Demo