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Leveraging Patient Registries to Assess Safety and Product Performance in the Post-approval Arena
The drug development path today is more challenging and expensive than ever. The cost of bringing a new drug to market is estimated at somewhere between $500 million and $1 billion. With this intense development investment, it’s critical, then, for the drug to remain on the market after approval—an outcome that is not nearly as certain today as it was in decades past.
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Managing risk:
Optimized delivery of pharmacovigilance services to sponsor organizations through risk minimization strategies: A CRO approach
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.
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ICON Profile
Leanne Larson,Vice President, Registry Consulting, ICON Clinical Research, Lifecycle Sciences Group
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Did you know?
Fast Facts about ICON and Drug Safety
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ICON Webinars
ICON will be hosting a series of webinars on Drug Safety Reporting, Regulations, and Risk starting May 2008. For more information, contact info@iconclinical.com.
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