AI-Powered Periodic Benefit-Risk Evaluation Reports Automation Smart • Compliant • Efficient
Transform complex pharmacovigilance reporting into streamlined, AI-driven intelligence.
Automate Periodic Benefit-Risk Evaluation Reports with accuracy, compliance, and speed.
Watch PBRER AI In Action
Experience how PBRER AI simplifies pharmacovigilance workflows and accelerates regulatory submissions through intelligent automation.
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AI-Assisted Generation
Automatically draft PBRER sections using integrated safety and clinical data sources.
Regulatory Compliance
Ensure adherence to global pharmacovigilance guidelines including ICH E2C(R2) standards.
Workflow-Driven Collaboration
Streamline authoring, review, QC, and client approval processes through role-based workflow management.
Intelligent AI, At your fingertips
Features & Benefits
AI-Driven Report Drafting
Generate structured PBRER sections with contextual AI assistance for faster authoring and review.
- Automated section drafting
- Benefit-risk analysis support
- Contextual data synthesis
Smart Review & Collaboration
Enable medical writers, reviewers, and safety teams to collaborate seamlessly in one platform.
- Multi-user collaboration
- Reviewer comments & tracking
- Version control
Document Support
Supports seamless upload and processing of PDF, Word, Excel, and other formats for streamlined reporting.
- Automated format parsing
- Bulk document upload
- Standardized outputs
Audit Readiness
Maintain complete visibility, audit readiness, and compliance throughout the reporting lifecycle.
- Comprehensive audit trails
- Secure document management
- Lifecycle traceability
ICH E2C(R2) Standards
Ensure adherence to global pharmacovigilance guidelines including ICH E2C(R2) standards.
- Guideline-aligned templates
- Automated compliance checks
- Submission-ready formats
Secure Workflows
Maintaining regulatory compliance and audit traceability is critical. We provide secure workflows.
- End-to-end encryption
- Role-based access control
- Complete audit trails and version control.
Onboarding & Planning
Week 1
Data collection
Source data gathering
Collect safety data from clinical trials, post-marketing surveillance, literature, and spontaneous reports within the reporting interval.Week 2-3
Section authoring
Medical writing & AI drafting
Authors assigned to sections upload reference documents, generate AI drafts, review and edit content for each PBRER section.Week 4
Review & approval
Workflow level review
Sections pass through configured workflow levels author submits, reviewer checks, approver signs off. Each level locks the section.Ongoing
Report generation
Consolidated report
All locked sections are merged in order into the final PBRER document.
Industry Challenges We Address
Time-Intensive Report Preparation
Manual PBRER creation requires extensive effort across safety and medical teams. Our AI-driven automation significantly reduces preparation time and operational burden.
Version Control & Document Consistency
Managing multiple report revisions and maintaining consistent content across teams can be challenging. Our platform provides centralized version management, controlled updates, and complete document traceability for accurate and reliable reporting.
Compliance & Audit Readiness
Maintaining regulatory compliance and audit traceability is critical. We provide secure workflows, complete audit trails, and standardized reporting processes.
Ready to transform your workflows?
Join leading life sciences organizations leveraging AI-powered automation for faster, compliant, and efficient PBRER reporting.