Методология фармаконадзора должна соответствовать масштабу организации: три модели оценки рисков

Right-Sizing Signal Detection: Matching Pharmacovigilance Methodology To Organizational Scale By Dr. Mohit Raizada, BDS, Director, Signal Management Services, IQVIA Detecting emerging safety risks in clinical development requires more than good intentions — it requires the right process for your organization's size. Regulatory expectations are consistent across the industry: identify safety signals early, evaluate them rigorously, and document every decision with full transparency. But how organizations meet those expectations should reflect their actual data volume, portfolio complexity, and governance maturity. This white paper outlines three practical, evidence-informed models and the conditions under which each performs best. If your organization's current safety monitoring program was inherited rather than intentionally designed, this paper provides a framework to assess whether your approach truly fits your scale and a rationale for acting when it doesn't. Get unlimited access to: Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.