Observational Studies: Opportunities and Challenges for Drug and Devicemakers

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Observational Studies
Opportunities and Challenges for Drug and Devicemakers

In this report based upon a webinar given by Jeff Trotter, a 30-year industry veteran, you will learn everything you need to know about the opportunities and pitfalls that observational studies can offer your organization. You’ll learn:

  • The most effective uses of observational research in both the pre-approval and post-market phases
  • How to identify stakeholders and determine what kind of data they need
  • How the FDA's view of observational research is evolving

Drawing on a survey of more than 2,500 individuals representing a cross-section of the pharmaceutical, medical device and biotech industries, Trotter discusses how companies are using observational studies including:

  • The role of observational studies in the pre-approval v. the post-market phase

  • Using observational studies to establish baselines of real-world behavior and identify needs

  • Understanding stakeholders and their different needs

  • The importance of establishing SOPs specifically for observational studies rather than adapting clinical research procedures

Order today and get your product marketed faster by using observational studies.


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Who Will Benefit

  • Clinical project specialists
  • Clinical research associates
  • Compliance officers
  • Consultants/service providers
  • Data management and statistics personnel
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff
  • Study monitors
  • Study research coordinators
  • Study sponsors

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