Signal Detection
- Automated drug-event combination review
- Internal safety database signal detection support
- Follow-up aware case and event processing
- Case-based deduplication discipline
- Seriousness and priority-driven triage support
Enterprise Pharmacovigilance Signal Platform
VigiCore Signal Automation
Pharmacovigilance Signal Detection, Streamlined.
From data to signal in seconds.
VigiCore transforms internal safety data into structured, transparent, and audit-ready signal insights designed to support qualified reviewer decision-making at enterprise scale.
Built for MAHs
Scaled for CRO delivery
Positioned for SaaS growth
- Built for regulatory-grade pharmacovigilance workflows
- Audit-ready outputs by design
- Supports scalable, traceable, reviewer-friendly operations
Product Capabilities
Built to help PV teams move faster, document better, and scale with control.
Each capability block is optimized for speed, transparency, and low-friction review.
Reports & Evidence Packs
- Audit-ready PDF and Excel outputs
- Internal case-series validation reports
- PubMed literature validation support
- FAERS/openFDA and EU evidence support
- Signal Evaluation Report support materials
Signal Intelligence
- Disproportionality and prioritization analytics
- Comparator stability and sparse-data cautions
- Transparent reviewer-facing drill-down support
- Run history and controlled comparison workflows
- Multi-client segregation and audit trail support
Analytics & Review Support
Advanced signal methodologies presented in a reviewer-friendly operating model.
VigiCore presents analytical outputs clearly without disclosing proprietary implementation details.
Core Statistical Methods
- MGPS support for industry-standard Bayesian signal review
- IC support for validated, industry-standard disproportionality views
- PRR support for structured reviewer interpretation
- SDR support for comparative signal prioritization
- Chi-square review support for significance context
Reviewer Interpretation Aids
- 2x2 contingency-based signal review support
- Confidence-bound and trend review visibility
- Bayesian-style shrinkage views for context
- Run-to-run comparison support across data cuts
- Sparse-data cautions for careful interpretation
Why It Matters
- Faster signal detection and review preparation
- More consistent calculation workflows at scale
- Transparent outputs for qualified reviewers
- Lower manual effort in repeated assessments
- Better signal intelligence packaging for teams
Compliance & Validation
Regulatory-aware by design, with clear boundaries around reviewer responsibility.
Regulatory Readiness Support
- Designed with EU GVP Module IX principles
- Supports ICH E2E-style signal evaluation concepts
- Structured data discipline aligned with ICH E2B expectations
- 21 CFR Part 11-aware and Annex 11-aware design direction
- ALCOA+ data integrity considerations in traceability design
Validation & Audit Controls
- Audit-ready outputs by design
- Documented methodology and threshold capture
- Role-based access and audit trail support
- Controlled comparison across repeated runs
- Reviewer-friendly disclaimers and evidence context
Why This Platform
Enterprise value communicated in seconds.
Speed
- From data to signal in seconds
- Faster output generation for review cycles
- Less spreadsheet handling and manual rework
- Quicker preparation for follow-up assessments
Consistency
- Configured workflows applied repeatedly
- Transparent reviewer-facing calculation outputs
- Controlled logic across products and portfolios
- Reduced workflow variability between teams
Automation
- Reduces repetitive manual workload
- Supports scalable signal operations
- Automates repetitive reporting steps
- Frees reviewers for higher-value evaluation
Scalability
- AWS-ready SaaS architecture direction
- Multi-client and multi-tenant expansion potential
- Secure HTTPS delivery via CDN
- Built for pharma-grade operational scale
When signal detection workflows are automated with consistent configuration, supported by audit trails and transparent reasoning, variability is reduced and reviewer confidence is strengthened.
This approach supports high standards of quality, traceability, and audit readiness in pharmacovigilance signal review.
Workflow
Clean handoff from source data to supported PV review.
Upload Safety Line Listing
Structured intake for repeatable downstream review.
Confirm Column Mapping
Controlled field alignment before processing begins.
Standardize Source Data
Consistent formatting for stable signal workflows.
Run Signal Detection
Configured analytics applied across the dataset.
Review Transparent Results
Reviewer-facing outputs support rapid interpretation.
Compare Runs
Track change, continuity, and repeated data cuts.
Gather External Evidence
Bring supportive public evidence into the review pack.
Generate Audit-Ready Reports
Produce traceable outputs for internal validation support.
Support Medical/PV Review
Final assessment remains with qualified reviewers.
Logic-driven. Automation-controlled. Trusted for transparent, repeatable signal review.
VigiCore is built on documented workflow logic and controlled automation rather than subjective assumptions, helping teams strengthen consistency, traceability, and reviewer confidence.
For Investors
A clear SaaS story for a market that still runs too much of signal work manually.
Market Need
- PV teams still depend on Excel-heavy workflows
- Repeated data cuts create avoidable review cost
- Reporting and evidence gathering remain fragmented
- Scalable signal operations need better tooling
- Regulatory scrutiny increases demand for traceability
Differentiation
- Combines automation, reporting, and signal intelligence
- Supports faster signal detection and audit-ready outputs
- Built for reviewer-facing transparency, not black-box claims
- Designed for enterprise and service-provider workflows
- Commercially attractive to clients and strategic partners
Scalability & Revenue
- AWS-ready SaaS deployment for efficient expansion
- Multi-client rollout across pharma and CRO accounts
- Subscription model with report-based upsell potential
- Cost reduction through workflow automation
- Positioned for strategic commercialization partnerships
Seeking Strategic Growth Partners
VigiCore Signal Automation is seeking strategic investment, marketing, and enterprise partnership opportunities to scale the platform into a broader SaaS-based pharmacovigilance automation ecosystem.
Contact / Demo Request
Request a demo, submit an RFP, or start a strategic discussion.
Conversation Types
- Demo requests for enterprise PV teams
- RFP and proposal discussions
- Strategic partnership exploration
- Investment and commercialization dialogue
- Technical fit and integration conversations
Designed for deployment on AWS cloud infrastructure with secure HTTPS delivery via CDN.