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home > epc > winter 2002 > meeting new pharmacovigilance challenges - the need for outsourcing

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European Pharmaceutical Contractor Meeting new Pharmacovigilance Challenges - the Need for Outsourcing
Until recently the idea of outsourcing pharmacovigilance activities fell outside the comfort zone of all but a few pharmaceutical companies. This was in the main due to fear of the legal ramifications if the outsourcing partner 'got it wrong', and a reluctance to be the first to adopt the outsourcing model. It was also a reflection of the limited choice of both service providers and scope of services available at the time. In 1997 one of the authors, while working for a virtual development company, systematically examined the provision of such services and could identify only a few companies capable of meeting fully outsourced pharmacovigilance requirements. In contrast, today's marketplace offers a wide range of pharmacovigilance services provided by both large and small companies. These may form part of a suite of services offered by CROs, be the core business of specialist companies, or form part of the expertise available through the growing network of freelance individuals, many of whom are former pharmaceutical company employees. This growth in the services available for pharmacovigilance outsourcing has been driven by the annual increase in the volume of data generated both in terms of number of individual adverse event case reports and contributing organisations. This has prompted both the regulatory authorities and the pharmaceutical industry to seek more efficient methods of processing product adverse event data with the goal of both improving public safety and reducing the cost overhead for marketing and support of pharmaceutical products in the European Community and beyond.
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By Liz Nowell, Pharmacovigilance Manager, Alan Rawling, Managing Director of Assured Information Systems and Dr Michael Bowden, Managing Director of the European Division, Health Decisions

Liz Nowell is the Pharmacovigilance Manager at Health Decisions, a global contract research organisation. Liz has over 10 years' experience in pharmacovigilance and has worked for two major pharmaceutical companies and a large CRO prior to joining Health Decisions.

Dr Alan Rawling is Managing Director of Assured Information Systems and has worked on developing a flexible, workflow-driven pharmacovigilance system.

Alan has 20 years' experience of software product delivery and support in the pharmaceutical industry. In addition he has acted as a Consultant on validation and quality standards for the Food and Drug Administration and Medicines Control Agency.Dr

Michael Bowden is the Managing Director of the European division of Health Decisions and has over 15 years' experience in medical affairs and pharmacovigilance gained in several major pharmaceutical companies. Michael is a regular contributor of articles on the practical use of technology in clinical trials.