SOURCE: Cutting Edge Information

Cutting Edge Information

September 15, 2016 08:17 ET

79% of Standalone Pharmacovigilance Groups Contribute to Drug Safety Initiatives Throughout the Product Lifecycle

RESEARCH TRIANGLE PARK, NC--(Marketwired - September 15, 2016) - A variety of teams contribute to the development and execution of drug manufacturers' drug safety strategies. Out of all functions, standalone pharmacovigilance groups contribute to the largest percentage -- 79% -- to their companies' drug safety initiatives. However, medical affairs teams are essential to drug safety training at 43% of all surveyed teams, while compliance teams contribute at 21% of companies, according to a new pharmaceutical benchmarking study published by Cutting Edge Information.

According to the study, Pharmacovigilance: Balance Signal Detection and Case Management Responsibilities with Emerging Drug Safety Regulations, surveyed teams also call on functions such as clinical development, marketing or brand teams, regulatory affairs, and risk management teams at much smaller percentages. Out of all surveyed teams, medical affairs groups are only involved in drug safety training 14% of the time. However, country-level teams use this function in these activities 40% of the time.

"Pharmacovigilance impacts so many parts of a drug company's overall organization, which is why many groups contribute to the drug safety process," said Sarah Ray, senior research analyst at Cutting Edge Information. "While standalone drug safety groups are obviously a driving force behind these strategies, cross-functional support is the key to maintaining compliant actions."

Drug safety groups acquire the expertise from regulatory and medical affairs, clinical operations and even commercial functions to aid with the wide range of tasks. These tasks range from submitting regulatory approval to developing reports to case management.

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/, uncovers drug safety and pharmacovigilance best practices and benchmarks. 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 benchmarking study is designed to help drug safety executives in the following ways:

  • Determine best-fit budget allocations to different pharmacovigilance activities.
  • Identify the percentage of costs teams should outsource for different drug safety activities.
  • Explore companies' case management approaches and gain top executives' recommendations concerning for improving existing case management procedures.
  • Determine what percentage of drug safety funding should come from different groups within a life sciences organization.
  • 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.

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

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