SOURCE: Xtalks

Xtalks Webinars

February 13, 2017 07:30 ET

Designing an Effective Clinical Trial, New Webinar Hosted by Xtalks

The session will focus on various aspects of designing and conducting clinical trials for submission to the FDA, as well as, communicating with FDA during the pre-submission and submission process

TORONTO, ON--(Marketwired - February 13, 2017) - On Tuesday, March 7, 2017, Xtalks will host a complimentary webinar featuring Richard Kotz, Senior Medical Research Scientist, Biostatistics from NAMSA as the keynote speaker.

The advice provided during the session will be based on Richard Kotz's 25 years of experience gained as a statistical reviewer and biostatistics team leader at FDA's Center for Devices and Radiological Health. He, along with his team of biostatisticians, has reviewed 100's of medical devices for a wide variety of medical conditions. He has also participated in numerous FDA/sponsor meetings.

Utilizing this experience and expertise, Mr. Kotz will share insights into key topics related to successful study design, with an emphasis on those trial elements which were most likely to lead to poorly designed and executed clinical trials.

The discussion will provide best practices and tips on getting the most out of communications with the FDA and include a Q&A period with the audience.

Other topic areas include:

  • Making the most of feasibility studies
  • The critical importance of pilot studies
  • Common pitfalls in the design and conduct of pivotal trials
  • Development and negotiation of non-inferiority margins in a non-inferiority trial
  • Some important aspects of investigational site selection
  • Communicating with FDA during the pre-submission and submission process

For more information or to register for this free webinar visit: Designing an Effective Clinical Trial

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies to private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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