Signal Management in Pharmacovigilance: Inspection-Ready Signal Detection & Risk Control by GPLACO SOLUTIONS

Biggest Industry Challenge

Signal Management fails not because signals are missed, but because:

• Signals are identified too late

• Statistical outputs are not medically contextualized

• Documentation is not inspection-ready

• Signal actions are not traceable end-to-end

Health Authorities increasingly expect proactive signal governance, not reactive signal discussions.

How GPLACO SOLUTIONS Solves It

At GPLACO SOLUTIONS, signal management is treated as a controlled lifecycle, not a periodic activity.

We deliver:

• Structured signal detection using quantitative + qualitative methods

• Medical validation aligned to indication, exposure, and risk context

• End-to-end signal tracking, documentation, and closure

• Clear linkage between signals → risks → RMP updates

Our frameworks are aligned to:
✔ ICH E2E
✔ GVP Module IX
✔ US FDA, EMA, MHRA expectations

Results Our Clients Achieve

✔ Statistically and medically justified signals
✔ Zero inspection findings related to signal management
✔ Faster decision-making with documented rationale
✔ Health Authority-ready signal evaluation reports

This is why sponsors trust GPLACO SOLUTIONS for inspection-ready signal governance.

Connect with us for a free consultation – Contactus@globalplacosolutions.com