Online Signal Management: A Systems-Based Approach That Delivers New Analytical Capabilities and Operational Efficiency
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June S. Almenoff, MD, PhD, FACP Vice President, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Research Triangle Park, North Carolina Gregory Powell, MBA, PharmD Principal Clinical Safety Scientist, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Research Triangle Park, North Carolina Rich Schaaf Vice President, Lincoln Technologies, Inc, Waltham, Massachusetts David Fram Vice President, Lincoln Technologies, Inc, Waltham, Massachusetts John M. Fitzpatrick Manager, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Harlow, United Kingdom (during the development of OSM) Annmarie Pendleton Principal Clinical Safety Scientist, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Harlow, United Kingdom (during the development of OSM)
Online Signal Management: A Systems-Based Approach That Delivers New Analytical Capabilities and Operational Efficiency to the Practice of Pharmacovigilance Traditional approaches to postmarketing pharmacovigilance have been primarily qualitative and paper based. We describe the development and implementation of online signal management (OSM), a new systems-based platform for pharmacovigilance that supports prioritization of safety issues, in-stream review and data retrieval, aggregate-level analysis of data patterns, and knowledge management. By providing an integrated view of the information needed to detect and evaluate safety signals, OSM enhances the efficiency of the pharmacovigilance process. The system enables pharmacovigilance professionals to triage
Nassrin Payvandi, PhD Therapy Area Director, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Greenford, United Kingdom Nancy Yuen, PharmD Director, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, Research Triangle Park, North Carolina
Key Words Pharmacovigilance; Drug safety; Signal detection; Signal management; Safety signal Correspondence Address June S. Almenoff, Safety Evaluation and Risk Management, Global Clinical Safety and Pharmacovigilance, GlaxoSmithKline, 5 Moore Drive, Bldg. 5.4404.4C, Research Triangle Park, NC 27709 (e-mail: [email protected]). David Fram and Rich Schaaf are employees of Lincoln Technologies (a subsidiary of Phase Forward Inc), a software development company that markets the WebVDME pharmacovigilance signal detection and signal management software referenced in this article. All images of online signal management are reproduced with permission of Lincoln Technologies.
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INTRODUCTION BACKGROUND The aim of pharmacovigilance is to protect patients and public health by monitoring medicines throughout a product’s life cycle. It includes ongoing characterization of the safety profile of a product so that the most accurate and current information can be used in managing and communicating
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