Observational Studies - Webinar CD/Transcript

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Observational Studies: New Frontiers in Gathering Evidence

Whether you market drugs or devices, you must demonstrate convincingly that your products are safe and effective in the real world.

Observational studies are increasingly critical in compiling and communicating evidence of clinical, economic, and humanistic value.

Will the observational studies you create deliver persuasive data? Do you have the skill set to construct persuasive and scientifically sound patient registries?

Make sure you know:

  • What constitutes reasonable and compelling evidence
  • What stakeholders are demanding real world evidence
  • How to cost-efficiently run an observational study

Jeff Trotter, president of Continuum Clinical, will walk you through the opportunities and pitfalls of observational studies. He will cover:

  • Key findings from Continuum’s 9th Survey on Observational Research
  • The critical link between strategy and operational efficiency in observational studies
  • Setting internal and external expectations for real world evidence
  • Best practices for ensuring clinical and commercial collaboration in support of observational studies and patient registries

Develop critical evidence faster by using observational studies.

  • 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

Jeff Trotter, President, Continuum Clinical

Jeff Trotter has enjoyed a diverse career in the healthcare industry spanning the past 30 years. As an entrepreneur, researcher, consultant and innovator, Jeff has been a pioneer in the evolving health economics and outcomes research community, and is an industry leader in the design and implementation of research studies generating “real world” evidence. Having engineered the acquisition of his internationally known research and consulting firm, Ovation Research Group, Jeff has been in executive management with other global clinical research organizations, has spoken widely in front of varied industry audiences and has published over 50 original articles and research papers — including a book for the American Hospital Association, The Quest for Cost-Effectiveness in Healthcare: Achieving Clinical Excellence While Controlling Cost and is currently co-editing another book on observational research.