SOURCE: Cutting Edge Information

Cutting Edge Information

August 03, 2016 08:39 ET

40% of Global Pharmaceutical Teams' Drug Safety Budgets is dedicated to Case Management

Drug safety budgets fund numerous activities, ranging from safety and technology services to due diligence projects and risk mitigation strategy

RESEARCH TRIANGLE PARK, NC--(Marketwired - August 03, 2016) - The largest portion of global pharmaceutical organizations' drug safety budgets is allocated to case management, according to new survey data published by Cutting Edge Information.

Surveyed global teams dedicate an average 10% more budget to case management than surveyed country-level teams. This is not the case for all drug safety activities. For instance, global teams typically only spend 2.3% of their total budgets on regulatory submissions, while country-level teams spend an estimated 13.3% of their overall budgets on this same activity.

According to the study, Pharmacovigilance: Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulations, surveyed global drug safety teams allocate 11% of their overall budgets to pharmacovigilance training. At the same time, country-level drug safety teams use slight more than 2% of their budgets for training activities. Global teams also spend much more on safety and technology services than country-level teams do.

The study also found that surveyed global teams allocate nearly twice the percentage of resources to these activities than surveyed country-level teams do. Other activities that require much less spending for global and country-level teams include:

  • Risk mitigation strategies (REMS)
  • Project management
  • Medical services
  • Due diligence projects.

"Global and country-level teams have notable discrepancies in their drug safety budget allocations, said Sarah Ray, senior research analyst at Cutting Edge Information. "Individual teams also differ in how they structure their budgets. For example, safety and technology can be a substantial expenditure for certain teams."

Global pharmaceutical organizations, as a whole, still allocate the largest percentages of their budgets to case management. Most surveyed global teams have overall increases in drug safety budget between 2014 and 2016. For pharmacovigilance responsibilities, costs for specific activities vary widely by team region, company size and individual situation.

Pharmacovigilance: Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulations, available at, uncovers best practices and benchmarks associated with drug safety. The report's data were compiled from global and country-level teams for large and small pharma and biotech companies, as well as medical device companies. The report is designed to help drug safety executives in the following ways:

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

For more information about Cutting Edge Information and its drug safety benchmarking data, visit

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