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Choosing the right pharmacovigilance solution

You know this from experience. Successfully managing a pharmaceutical business — whether it’s lean and entrepreneurial, or medium-sized and growing — is a daily battle to get the most out of available resources. You need the best people, in the right positions, delivering the greatest return on investment.
What about pharmacovigilance (PV)? Is that really where your in-house personnel can create the most value?
Two things make this a hard decision. PV is critically important. There’s too much at stake to get it wrong. And it’s extremely complex — requiring a hard-to-find combination of talent, experience, accuracy and engagement. PV is much more than simply meeting a set of regulatory requirements.

Weighing the benefits: In-house or outsourced?
Partnering with a company that specializes in drug safety lets you focus on your core business — while they build and monitor your products’ safety profiles. But it’s reasonable to ask: Will they provide the level of monitoring you need to effectively manage risk?
A recent article in a leading business daily discussed that very question. The argument is that outsourcing carries risk. However, it should not be assumed that outsourcing equates to inferior product knowledge and less detailed attention to safety monitoring than can be provided in house. The risk is not outsourcing; it is outsourcing to the wrong company. In fact, the potential benefits of outsourcing are too great to ignore.

Choosing the right partner
Intelligent drug safety involves real-time continuous monitoring, understanding of biochemistry and pharmacology, and keen investigation skills to ensure early recognition of potential signals. Partner with a company who is as knowledgeable as your own staff.
Deliberate and thoughtful pharmacovigilance is seldom accomplished with large outsource providers who use many individuals to process data for any client or product in a rotational model. The level of monitoring needed requires a core group of skilled individuals assigned to monitor your product on a daily basis throughout the product’s life cycle. DSA provides this, with acute attention to detail — which mitigates the risk of discovering a safety issue when a crisis occurs.

Exclusively focused on pharmacovigilance
Ashfield Pharmacovigilance effectively operates as an extension of your PV department — with the same intimate familiarity with your safety data, organizational sensitivities and reporting deadlines. As a domestic company located in Durham, NC’s Research Triangle Park, Ashfield Pharmacovigilance offers you an alternative to the reservations that come with outsourcing offshore. With over 15 years’ experience, we bring the dedication and skills you need to successfully navigate PV:

  • Expertise in compliance, regulation and implementation
  • Pharmacovigilance staff consisting of 90% life science and healthcare professionals
  • Scalable, robust systems that can be tailored to fit your company’s needs
  • Full-time proactive attention to detail
  • Increased efficiencies
  • The personalized attention of a small company, with the support infrastructure of a large organization
  • Intensive training and rigorous quality oversight
  • Database and IT services
  • Extensive yearly case management responsibility in all healthcare categories

Get more value from your internal resources

Contact Ashfield Pharmacovigilance to see if an outsourced solution may be a better way to handle your PV strategy. Please call Trent Wadford at 919-328-5937. Or email

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