Medical affairs teams at the heart of Phase IV studies

Dec 20, 2016

Recent article demonstrates the pivotal role of medical affairs

Medical Affairs teams have long played a role in the life cycle of a drug going to market and staying in market.  But, is their role changing?  Are Medical Affairs teams becoming the lynchpin to Phase IV studies?  Are they finally getting the “respect” they deserve given the information they handle?  And, if they are stepping up in Phase IV studies – what does it mean to the information they gather, how they report it, and to whom they report it to?

The main objective of Phase IV post-marketing studies is to collate data on the drug’s effect in various populations and its efficacy during long-term use. A recent article in Outsourcing-Pharma.com highlighted the pivotal role medical affairs teams play in these studies.

The survey results showed:

  • “93% of medical affairs teams are integral to the strategic planning process, with Compliance and Regulatory teams showing 73% and 63% involvement, respectively”
  • “68% of medical affairs teams are involved directly with the study execution, with Clinical Development and Compliance teams showing 50% and 36% involvement, respectively”

In addition to the core objective, Phase IV studies can provide vital data which will shape the drug company’s commercial marketing strategy – and medical affairs teams are at the heart of this process.

With the likelihood of post-marketing studies becoming mandatory practice in the future, it seems fitting that medical affairs professionals, with their expertise in multi-channel communication (with Healthcare Professionals, Medical Science Liaisons, Sales, medical information groups) would drive Phase IV study strategy.  But, they can only do this if they are armed with the right insight tools and right processes, i.e. using continued insights from internal and external customers to refine and interpret the results.

With this in mind, medical affairs teams can plan now for future success: ensuring the capabilities are in place for handling increased multi-channel communication while efficiently handling reports from multiple internal and external sources.

Is your medical affairs team challenged with having to handle increasing channels of communication? Learn more about ArisGlobal’s medical communications software and find out how it can help provide insights, automate, integrate and streamline your medical affairs processes.

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