SOURCE: Cutting Edge Information

Cutting Edge Information

August 31, 2016 07:42 ET

70% of Pharmaceutical Companies Have a Global Level Phase 4 Groups

Post-marketing study groups exist across global and regional levels

RESEARCH TRIANGLE PARK, NC--(Marketwired - August 31, 2016) - A new study published by Cutting Edge Information reported that 70% of surveyed pharmaceutical firms employ Phase 4 groups at the global level. However, a small percentage of surveyed global teams reported utilizing regional post-marketing teams. Furthermore, 50% of surveyed global teams also enlist country-level teams to perform post-marketing studies.

The newly published benchmarking study, Post-Marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, explains how region and company size affect Phase 4 study groups in surveyed companies. For example, 50% of global teams use country-specific post-marketing teams, while only 13% of US teams use this same approach. Regarding company size, only 22% of surveyed small pharmaceutical firms use country-specific post-marketing teams, while 55% of surveyed Top 10 pharma companies allocate responsibility to country-specific Phase 4 teams.

"Regional Phase 4 teams differ from country-specific teams in their geographic reach," said Natalie DeMasi, research team leader at Cutting Edge Information. "Global teams' post-marketing reporting structures and divisions of responsibility may look different from company to company. Some companies may have post-marketing structures that are centralized at the global level but are decentralized by region."

Unfortunately, different regional post-marketing structures can complicate companies' abilities to align their activities. For example, in the US, one surveyed company's Phase 4 study teams have very different needs, which largely depend on therapeutic area. In effect, these distinct needs create an additional level of separation across the company's therapeutically aligned US Phase 4 teams.

Post-Marketing Study Excellence: Design Phase 4 Trials to Demonstrate Real-World Outcomes, available at, provides insights and best practices on Phase 4 research ownership, budget resources and staffing for post-marketing studies. The report also includes trend analysis and metrics on interventional and observational studies, as well as the effectiveness of study outcomes due to early planning. Report highlights include:

  • Determining the best-fit post-marketing research alignment for global and regional-level teams.
  • Identification of Phase 4 study team staffing trends.
  • Key recommendations for planning the number of Phase 4 studies per product.
  • The latest trends concerning observational and interventional studies.

To learn more about Cutting Edge Information and its Phase 4 benchmarking report, please visit

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