Signal Management

A safety signal can emerge at any point in a product’s life, from a single case report, a pattern in your data or a paper in a local journal. Finding it early is what protects patients and keeps you ahead of regulators rather than reacting to them.

Our pharmacovigilance team works as an extension of yours, reviewing safety data systematically to identify and manage signals for both investigational and authorised medicinal products.

We work in modern cloud-based safety platforms, including Veeva Vault Safety, so you have real-time oversight of your data and a traceable record of every decision. Our processes are documented, inspection-ready and built to GVP Module IX standards.

What we do

• Detection and validation: continuous review of your safety data, and confirmation that a signal has enough evidence behind it to warrant further analysis.
• Prioritisation and assessment: ranking signals by public health impact and severity, then establishing the level of risk and the effect on your product’s benefit-risk profile.
• Recommendation for action: from product information updates and safety communications through to further studies, with the documentation regulators expect.
• Exchange of information: communicating validated signals and resulting actions to regulators and healthcare professionals, on time and in the required format.

We draw on data from across your safety estate, including ICSRs and adverse event reports, global and local literature monitoring, clinical study data, aggregate reports, RMPs and EudraVigilance.

Stand-alone or integrated

Signal management can sit alongside your existing pharmacovigilance arrangements or form part of wider safety support from our team. Either way, it scales with your portfolio and your markets.