Case Study

Inside One Pharma Org’s Pharmacovigilance Literature Monitoring Process

Literature review is a core component of pharmacovigilance — but growing data sources and regulatory requirements can make the process a daunting task. Here’s how one global pharmaceutical company improved their literature monitoring process with RightFind® Enterprise, CCC’s content workflow solution.

When a new head of information and knowledge management came on board at a leading global pharmaceutical organization, one of her first tasks was to assess how safety searches were being done in accordance with various regulatory bodies.

While she knew the information center was a key player in the pharmacovigilance search process, she quickly realized the information center and the pharmacovigilance departments needed to act as a joint force in this initiative — and at the time, the two divisions were siloed.

The organization decided to implement CCC’s RightFind, which allows for one, cloud-based library space for colleagues to monitor, review and automate the literature review process.

Months into the RightFind literature review process, both the information center and the pharmacovigilance departments were “delighted” by the ease of use. They admitted the work to coordinate the two databases was extensive, but it has made the pharmacovigilance review process more efficient and ensures all records are being reviewed.

Pharmacovigilance teams are the experts in drug safety. [Information managers] are the experts in documents and creating robust searches. We needed to work together to play to our strengths.”

The FDA received over 1.8 million adverse event and medication error reports associated with the use of drug or biologic products in 2017—a 400% increase from ten years earlier. It’s easy to see why many pharmacovigilance teams are struggling to manage this process effectively.

Consider the following requirements for a literature monitoring tool:

  • An automated literature search process that would store and archive literature search results electronically.
  • Simplified access to articles cited from search queries.
  • A familiar and easily navigable interface.
  • Minimal duplication of search results.
  • Search results that would be automatically accessible for all members of the drug safety team.
  • An established process to determine what had been reviewed by safety team.
  • A manageable audit trail.

Interested in more information on this project?

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