Strengthen routine signal management
Cencora customizes monitoring and signal detection activities to your requirements, helping you maintain reliable, high-quality, trackable data in line with applicable pharmacovigilance guidance.
Our teams review safety information across individual case safety reports (ICSRs), literature, health authority sources, EudraVigilance Data Analysis System (EVDAS), FDA Adverse Event Reporting System (FAERS), and other agreed data sources.
We support the full workflow from detection through validation, prioritization, assessment, action recommendation, and communication so you can make timely, evidence-based safety decisions.
Our teams review safety information across individual case safety reports (ICSRs), literature, health authority sources, EudraVigilance Data Analysis System (EVDAS), FDA Adverse Event Reporting System (FAERS), and other agreed data sources.
We support the full workflow from detection through validation, prioritization, assessment, action recommendation, and communication so you can make timely, evidence-based safety decisions.
Manage signal detection demands
Effective signal management requires broad source review, sound clinical judgment, and consistent documentation. Cencora helps you manage these needs with structured processes and specialized safety expertise.
Complex source monitoring
Review safety information across ICSRs, literature, health authority sites, EVDAS, FAERS, and other agreed sources without losing traceability or consistency.
Evidence-based validation
Evaluate potential signals using clinical relevance, prior knowledge, and supporting data so only meaningful findings move forward for deeper analysis.
Timely follow-through
Advance validated signals through prioritization, assessment, recommended actions, and stakeholder communication to support ongoing benefit-risk management.
Comprehensive signal management support
You get tailored monitoring and signal detection activities aligned to your product portfolio, data environment, and reporting needs.
Support can include qualitative and quantitative review, signal validation and prioritization, signal assessment, EVDAS review, action recommendations, and communication support with health authorities and other stakeholders.
Support can include qualitative and quantitative review, signal validation and prioritization, signal assessment, EVDAS review, action recommendations, and communication support with health authorities and other stakeholders.
What we offer
Signal detection
Qualitative and quantitative review of safety information across agreed sources to identify potential new risks or new aspects of known risks.
Signal validation
Clinical evaluation of detected findings to confirm whether available evidence supports further analysis of a potentially causal association.
Signal prioritization
Structured prioritization of validated signals based on seriousness, novelty, public health impact, affected populations, and evidence strength.
Signal assessment
Comprehensive evaluation of validated signals using internal and external data sources to support causality assessment and risk characterization.
EVDAS review
Routine and signal-specific review of EudraVigilance Data Analysis System outputs, including disproportionate reporting and reporting odds ratio findings.
Action support
Recommendations for regulatory, pharmacovigilance, and communication actions in consultation with your team and relevant stakeholders.
Why choose Cencora for monitoring and signal detection
Tailored oversight model
Monitoring activities are customized to your requirements, data sources, and product safety profile fit-for-purpose signal management.
End-to-end safety workflow
Support spans detection, validation, prioritization, assessment, action planning, and communication within one structured service model.
Broad source intelligence
Reviews integrate case data, literature, health authority outputs, EVDAS, FAERS, and other relevant safety information sources.
Expert insight
In signal detection and signal management, there is potential to use AI tools to identify patterns, as long as PV teams can interpret those patterns.
— Michael Day, PhD
What Project Elsa means for the FDA’s approach to AI
Related solutions
Clinical trial pharmacovigilance activities
Manage clinical trial safety activities with expert support for adverse event processing, safety writing, and compliant submissions across global studies.
PharmaLex is now Cencora
Safety monitoring and signal detection is part of our Commercialization support capability. Same team, same expertise, now with greater reach.
Need more information about safety monitoring and signal detection?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.