Clinical and Medical Safety

Clinical and medical safety guidance grounded in real expertise

You want confidence that the people supporting your safety decisions truly understand the stakes. That’s why our clinical and medical safety services are led by physicians with hands-on experience across development, post-marketing safety, and regulatory interactions. They’ve designed protocols, assessed complex cases, supported safety committees, and prepared organizations for health authority scrutiny. When you come to us with a trial event, safety signal, or protocol question, you get guidance shaped by clinical judgment and real experience, not templates or assumptions.

You’re expected to make the right safety call, every time

Event reports arrive without context. Protocols leave room for interpretation. Signals emerge unexpectedly. While others wait for direction, you’re expected to determine clinical relevance, decide what happens next, and stand behind the decision.

It gets harder when data points don’t align, trial results suggest one thing, medical judgment another, and stakeholders look to you for clarity on patient safety.

You shouldn’t have to navigate that alone. You deserve clear clinical insight, sound medical reasoning, and support that helps you make confident, defensible decisions without hesitation.

It gets harder when data points don’t align, trial results suggest one thing, medical judgment another, and stakeholders look to you for clarity on patient safety.

You shouldn’t have to navigate that alone. You deserve clear clinical insight, sound medical reasoning, and support that helps you make confident, defensible decisions without hesitation.

How we support you across clinical and medical safety

From protocol design through post-marketing oversight, we provide the medical insight you need to protect patients and move forward with confidence

Clinical Trial Safety Monitoring & Reporting

You shouldn’t have to chase clinical context or interpret trial events alone. Our Subject Matter Experts help you strategically plan, review, assess, and report safety data throughout your studies, giving you clear medical insight, timely evaluations, and support that keeps your trials compliant and your teams aligned.

Medical Safety Expertise for Marketed Products

Once your product is on the market, safety questions don’t slow down. We support you with planning of the PV systems, medical review of single cases and aggregate data, signal management, benefit–risk assessment, and overall clinical interpretation of post-marketing data so you can respond quickly, confidently, and consistently as new information emerges.

Protocol Development & Review Support

Your protocol should protect patients and prevent downstream safety issues. We help you refine study designs, safety language, e.g. stopping rules, adverse event reporting and other safety sections in Protocol, as well as in Investigator’s Brochures (IB) and Informed Consent Forms (ICF), and safety management plans so expectations are clear from the start and risks are anticipated, not discovered mid-study.

Clinical Trial Safety Monitoring & Reporting

Medical Safety Expertise for Marketed Products

Protocol Development & Review Support

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?

Still have questions?Can't find the answer you're looking for? Please chat to our friendly team.

Here’s what working with us looks like.

You share what’s happening

You walk us through your studies, post-marketing data, protocols, and safety concerns. We focus on understanding your reality, not forcing a template.

We build a safety approach around you

You receive a clear plan outlining responsibilities, timelines, and communication so you know exactly how we’ll support you across the lifecycle.

You get ongoing medical safety guidance

We provide clinician-led evaluation, ongoing monitoring, and interpretation as your product evolves, helping you stay confident, compliant, and supported.

You share what’s happening

You walk us through your studies, post-marketing data, protocols, and safety concerns. We focus on understanding your reality, not forcing a template.

We build a safety approach around you

You receive a clear plan outlining responsibilities, timelines, and communication so you know exactly how we’ll support you across the lifecycle.

You get ongoing medical safety guidance

We provide clinician-led evaluation, ongoing monitoring, and interpretation as your product evolves, helping you stay confident, compliant, and supported.

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.

You shouldn’t have to second-guess safety decisions