Post-Marketing Surveillance

Once a product is on the market, real-world safety monitoring becomes essential — and is often a specific condition of approval. PharmExpert designs and supports post-marketing surveillance and Post-Authorisation Safety Studies (PASS) that monitor safety in routine use and meet regulatory commitments.

We design surveillance programs and PASS protocols aligned to GVP Module VIII and ENCePP methodological standards, so the study is scientifically sound and acceptable to regulators. A well-designed study answers the safety question; a poorly designed one wastes time and invites criticism.

We manage data collection and analysis, and — crucially — integrate the findings back into the safety system, feeding signal management, the RMP and aggregate reports. Surveillance that sits in isolation adds little; surveillance connected to the rest of pharmacovigilance turns real-world data into action.

Where surveillance is a post-authorization commitment, we track the milestones and report outcomes so obligations are demonstrably met. The result is real-world safety insight that protects patients and keeps you compliant with your commitments.