Managing risk:
Optimized delivery of pharmacovigilance services to sponsor organizations through risk minimization strategies: A CRO approach

Donelle Bussom, RN, MSN • Senior Director, Drug Safety US • ICON Clinical Research
Doniel Jackson, MD • Senior Director, Drug Safety US • ICON Clinical Research
Lisa Bolitho, MSc • Associate Director, Drug Safety EU/Asia • ICON Clinical Research

Introduction

The outsourcing of Pharmacovigilance (PV) services can raise complex issues. As the scope of these services increases, CROs have obtained necessary technical expertise, but may underestimate the organizational infrastructure necessary to insulate themselves from global risk. A strong corporate emphasis on ethics, reinforced by experienced medical, regulatory and legal leadership should guide decision-making in high risk service areas While constraints may be imposed by Sponsors on providers in order to safeguard themselves and their product(s); with the ever changing regulatory environment, this may place both the Sponsor and its outsource partner at risk. A project risk minimization plan is a solution that not only provides both companies a roadmap for navigating though regulatory “grey-areas”, but also gives direction to all levels of operational staff in responding to demands that may unknowingly put either party at risk.

Successful implementation of Pharmacovigilance projects requires the preparation of processes that cover basic operating workflows and staff functions; however, a project risk minimization plan on a corporate or department level fills the gap that can exist between well written Sponsor and CRO standard operating procedures, project specific procedures, and comprehensive “safety plans”. The reason Project Risk Minimization plans can be so successful is that they are tactical in focus with emphasis on regulatory and situational risk vs. operational workflows, thereby reinforcing (not replacing) traditional process documentation. Although a number of topics merit inclusion in this type of plan, this article will review those areas consistently identified as problematic in global projects
across all phases of clinical development and postmarketing surveillance.

Specifically included will be discussion on four core areas: “Gray-area” requests including provision of “protocol waivers”; what constitutes and handling of late reports; outsourcing of the safety database, including electronic reporting; and the European (EU/EEA) Qualified Person for
Pharmacovigilance (QPPV).