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Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical Trials

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Manage episode 364958614 series 1533910
Content provided by K&L Gates LLP and L Gates. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by K&L Gates LLP and L Gates or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical trials, as well as notable planning considerations and regulatory requirements for both the industry sponsors and the academic medical centers, research institutions and other providers participating in clinical studies.

  continue reading

100 episodes

Artwork
iconShare
 
Manage episode 364958614 series 1533910
Content provided by K&L Gates LLP and L Gates. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by K&L Gates LLP and L Gates or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.

In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical trials, as well as notable planning considerations and regulatory requirements for both the industry sponsors and the academic medical centers, research institutions and other providers participating in clinical studies.

  continue reading

100 episodes

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