Signal Management

Signal management guided by medical judgment and real experience

You’re supported by PV specialists, safety physicians, statisticians, and analysts who have detected real signals, led multidisciplinary reviews, communicated findings to regulators, and built documentation that stands up in inspections, so decisions are reasoned, consistent, and defensible.

You’re expected to find real risks in a sea of noise

Alerts, trends, and data arrive constantly, often without context or alignment. You’re still expected to decide what’s meaningful, what needs action, and how to justify every conclusion, while balancing medical judgment, analytics, timelines, and regulatory expectations.

Heading: How we bring clarity and consistency to signal management

S You get end-to-end signal management support that combines medical judgment, analytics, and clear documentation, so decisions are timely, defensible, and inspection ready.

Signal Detection - Advanced Analytics & AI-Enhanced Methods

You shouldn’t have to dig through overwhelming data just to find what matters. We use advanced analytics, AI-assisted screening, and structured prioritisation to help you detect true signals earlier, so you can focus on trends that deserve your attention and act quickly when it counts.

Bringing All the Data Into One Picture

No single system gives you the full view. We strengthen interpretation by combining internal data with external sources such as EudraVigilance, FAERS, VigiBase, literature, and real-world data, giving you context instead of isolated alerts, and clarity instead of gaps.

Signal Validation & Evaluation - Medical & Statistical Expertise

Detection is only the beginning. We validate and assess potential signals using medical insight, epidemiology, and statistical review, so you understand clinical relevance, benefit–risk impact, and whether action is needed, backed by sound reasoning.

Signal Communication - Clear, Defensible Messaging

Once you know what’s real, you need to communicate it clearly. We help you prepare structured communication for regulators, partners, affiliates, and internal teams, so your decisions are understood, aligned, and easy to defend under scrutiny.

Signal Tracking & Audit Trails - Full Traceability & Documentation

You shouldn’t have to worry about whether your signal work will stand up in an inspection. We set up complete tracking, documentation, and audit trails, so every decision is traceable, consistent, and inspection ready.

Signal Detection - Advanced Analytics & AI-Enhanced Methods

Bringing All the Data Into One Picture

Signal Validation & Evaluation - Medical & Statistical Expertise

Signal Communication - Clear, Defensible Messaging

Signal Tracking & Audit Trails - Full Traceability & Documentation

Build a PV Department That Fits Your Timeline

Stop managing the burden of building from scratch. Get more information on our fully integrated modules and discover exactly how we stabilize your safety operations.

FAQ

How do I know if this service is the right fit for my situation?

Every iVigee service is designed to meet you where you are. Whether you’re building a PV function, stabilizing operations, or preparing for more complex change, the right fit depends on your products, timelines, and current pressures. When you reach out, we focus on understanding your reality first, not pushing a predefined solution. From there, we’ll help you determine whether this service makes sense now, later, or not at all.

Can services be tailored, or are they delivered as fixed packages?

Will iVigee work alongside our internal team and existing vendors?

What happens after I request information about a service?

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Here’s how we bring clarity to your signal process

You show us where the noise and uncertainty are

You walk us through your signal workflow, recent challenges, data sources, and where interpretation feels unclear or inconsistent. We focus on understanding your evidence, systems, timelines, and regulatory context, no assumptions, no templates.

We build a clear, structured signal management approach

You see exactly how detection, augmentation, validation, communication, and documentation will work together. Responsibilities, timelines, and scope are defined upfront, so you know what’s included and how decisions will be supported.

You get signal management you can defend with confidence

We help implement the approach, strengthen interpretation, improve documentation, and support clear communication. As new information emerges, we adapt with you, keeping your signal process stable, reasoned, and inspection ready.

You show us where the noise and uncertainty are

We build a clear, structured signal management approach

You get signal management you can defend with confidence

No fluff. No surprises. Just clarity and accountability.

Practical resources to help you make better PV decisions

Explore practical tools, insights, and resources designed to help you make confident PV decisions at your own pace.

Signal management that cuts through the noise