Observational Studies: Opportunities and Challenges for Drug and Devicemakers

$397.00
Quantity Discounts
1 - 2
$397.00
3 - 4
$357.00
5 - 6
$337.00
7 - 9
$317.00
10 - 9999
$297.00

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.

 

PDF Edition

Available Format

PDF Edition — $397

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

Multi-user Access

Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.