TheraSentriX
An AI-native pharmacovigilance solution designed to unify processes, connect data, and empower scientific teams from early clinical trials to post-marketing surveillance.
Pharmacovigilance Lifecycle from Clinical to Commercial
Unlike fragmented systems that silo clinical and post-marketing safety, TheraSentriX delivers end-to-end pharmacovigilance by seamlessly connecting data across all phases:
- Early Clinical Trials: Structured AE capture, early signal detection, protocol-level insights
- Late-Stage Trials: Integrated case management with automation-assisted triage and QC
- Post-Marketing: Continuous safety monitoring, global regulatory reporting, and real-world evidence integration
This unified approach ensures that safety is not an afterthought—it's embedded at every step.
Intelligent Literature Monitoring at Scale
Manual review of scientific literature is labor-intensive and error-prone. TheraSentriX transforms this process with AI-powered literature monitoring, capable of:
- Scanning and analyzing global medical journals and databases
- Automatically extracting and tagging relevant safety signals
- Routing findings to the right teams for faster case creation and triage
This ensures no signal is missed, and teams stay ahead of emerging risks
Aggregate Safety Reporting Made Simple
TheraSentriX automates and streamlines the generation of aggregate safety reports like PBRERs, DSURs, and PSURs:
- Templates pre-aligned with ICH and regional guidelines
- AI-assisted data aggregation from multiple sources
- Built-in consistency checks and completeness validation
What once took weeks can now be done in days—with higher accuracy and compliance assurance.
Real-Time Dashboards for Always-On Visibility
Stay in control with dynamic, real-time dashboards tailored to user roles and safety objectives:
- Live metrics on case volumes, signal trends, compliance KPIs
- Drill-downs by product, region, or report type
- Inspection-ready audit trails and traceable data lineage
Whether you're a safety leader, medical reviewer, or regulatory liaison, TheraSentriX provides clarity at a glance and confidence in every decision.
Built-In Compliance with Global Readiness
Compliance isn’t just an outcome—it’s engineered into TheraSentriX:
- Supports ICH E2B(R3), MedDRA, FDA FAERS, EMA EudraVigilance, PMDA, and more
- Smart triage and configurable rule engines to match evolving guidelines
- Audit-ready architecture with full traceability from data source to submission
Stay inspection-ready—always.
Real-Time Dashboards for Always-On Visibility
Stay in control with dynamic, real-time dashboards tailored to user roles and safety objectives:
- Live metrics on case volumes, signal trends, compliance KPIs
- Drill-downs by product, region, or report type
- Inspection-ready audit trails and traceable data lineage
Whether you're a safety leader, medical reviewer, or regulatory liaison, TheraSentriX provides clarity at a glance and confidence in every decision.
Relentless Safety
TheraSentriX is built for pharmaceutical organizations that refuse to compromise on compliance, efficiency, or patient safety.
Proactive Compliance
With AI-first infrastructure, unified data, and end-to-end lifecycle support, TheraSentriX enables teams to not only meet today’s safety demands—but anticipate tomorrow’s.
End the Search. Start with the Best in Pharmacovigilance
TheraSentriX is not just another safety tool—it's a next-generation PV system built on a connected, full-stack AI architecture, offering unmatched flexibility, compliance, and insight across every phase of drug development.
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