Substantiate Label Claims

You have a great story. We can help you tell it.

The SF-36v2® Health Survey has been referenced in over 2,500 randomized clinical trials to demonstrate drug efficacy, but that’s not all our patient-reported outcome (PRO) surveys are used for. Our surveys are used beyond the clinical trial world to substantiate label claims and product inserts. In fact, the recent MAPI PROLabels Adhoc Research Report found that 35 drugs or biologics currently on the market include label claims based on Optum PRO surveys. These drugs include Humira®, Arava®, Thyrogen®, Clarinex®, Allegra® and Lyrica®.

Our Outcomes Insight Consulting™ Division offers a comprehensive suite of strategic services to support the marketing and communications efforts of Life Sciences companies. These services use PRO tools and support to prove product claims so they can be used on product labels, inserts and promotional materials. Optum can help you:

  • Gain approval from the FDA for label claims
  • Differentiate your product from the competition
  • Develop powerful, well-defined marketing communications
  • Increase brand awareness
  • Educate customers and health care providers

Learn how Pfizer was awarded a label claim for XELJANZ® using our SF-36 Health Survey.