Pharmacovigilance Outsourcing a Plus

Editor’s Note: This article is part of a series examining popular peer-reviewed articles from years past called “Peer-Reviews Revisited: Why You Should Read Today.” You can read the other articles in this series here.

Pharmacovigilance is the next frontier for outsourcing in the pharmaceutical and biologics industry. In an era when effective pharmacovigilance during the clinical trial process can make the difference between success and failure for product licensing applications, outsourcing can be a vital step in the regulatory approval process.

“Traditional thinking suggests it is essential that pharmaceutical and biotechnology companies exercise complete control over their pharmacovigilance activities,” said James Sawyer, MD, Chief Executive Officer of industry consultants Prism Ideas in the United Kingdom. “Successful experiences of outsourcing other clinical activities are making outsourcing of safety services to specialized service providers a more attractive solution.”

The concept of pharmacovigilance is familiar, Dr. Sawyer said, but the practice has become a complex web of international standards and local requirements that can vary by jurisdiction. The International Conference on Harmonization and the Council for International Organizations of Medical Sciences guidelines describe the broad scope of pharmacovigilance. Regulatory requirements by the European Medicines Agency (EU), the Food and Drug Administration (US) and similar bodies set market-specific practices. It can be far more effective in terms of regulatory success and resource utilization to hire outside expertise than to develop and maintain in-house capabilities.

Outsourcing pharmacovigilance offers key advantages:

• As-needed access to specialists with the skills, technology and scale needed for specific programs and projects.

• Strategic planning and resources that enable projects to be launched more quickly and efficiently.

• Unblinding by the provider rather than the sponsor encourages more effective documentation and reporting of suspected unexpected serious adverse reactions.

• Independent, outside review of existing practices and procedures can radically improve efficiency, cost and speed of internal operations.

“The advantages of outsourcing a clear,” Dr. Sawyer said. “Utilizing the services of a specialist provider will benefit the manufacturer by defining and validating a drug’s safety profile and accelerating the delivery of new therapies to the marketplace.”