SOURCE: Cutting Edge Information

Cutting Edge Information

January 19, 2017 07:44 ET

70% of Global Drug Safety Teams Outsource Case Management Activities

RESEARCH TRIANGLE PARK, NC--(Marketwired - January 19, 2017) - Data published by pharmaceutical competitive intelligence firm Cutting Edge Information found that literature services are the most commonly outsourced item among 70% of surveyed pharmacovigilance teams.

In fact, 100% of surveyed country-level pharmacovigilance teams outsource literature services. However, 70% of surveyed global teams outsource case management activities. When assessing country-level teams, study participants noted that they outsource two activities in particular: literature services and regulatory submissions.

According to Pharmacovigilance: Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulation, 63% of surveyed global pharmacovigilance teams outsource literature services and regulatory submissions while half outsource safety and technology functions. Furthermore, 38% of surveyed global teams outsource the following drug safety activities

  • Periodic, PSUR and ASR development
  • Signal detection and management
  • Aggregate report development.

"Drug safety teams consider a number of factors when deciding whether to outsource pharmacovigilance activities," said Adam Bianchi, senior director of research at Cutting Edge Information. "Life science companies most often look to vendors for control over one of the three aspects regarding drug safety system, data quality, or costs."

When it comes to drug safety outsourcing, experienced vendors can help teams implement better processes for consistent tracking and audit training. Regarding data quality, pharmacovigilance teams may have quality drug safety systems, but may not be collecting the most relevant data. Therefore, bringing vendors can help teams reconstruct their channels to collect the most accurate data. In terms of costs, pharmacovigilance vendors can provide better management resources and offer companies the services they need at more reasonable costs than they may be able to do in-house.

Pharmacovigilance: Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulations, available at http://www.cuttingedgeinfo.com/research/clinical-development/driving-pharmacovigilance-success/, reveals best practices and benchmarks associated with drug safety. The report's data were compiled from global and country-level teams for large and small pharmaceutical and biotechnology companies, as well as medical device firms. The report is designed to help drug safety executives in the following ways:

  • Explore companies' case management approaches and learn top pharmacovigilance executives' recommendations for improving existing case management procedures.
  • Develop drug safety structures that align with the number of products within company pipelines and the relative complexity of these products.
  • Determine what percentage of drug safety funding should come from various groups within a life sciences organization.
  • Determine best-fit budget allocations to support different pharmacovigilance activities.
  • Identify the percentage of costs that teams should outsource for different drug safety activities.

For more information about Cutting Edge Information and its drug safety benchmarking data, visit www.cuttingedgeinfo.com.

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