DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
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We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
The Hidden Death Sentence for Trial Sites
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In this episode of KLF Deep Dive, Darshan Kulkarni uncovers the catastrophic risks clinical trial sites face when they fail to vet their staff against federal exclusion lists. We move beyond simple compliance to discuss the "off-the-books" penalties that can end a career or a company. If you’re in the life sciences, this is the legal shield you can't afford to ignore.
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If you are a clinical trial site, you must have a process of checking these lists to ensure that you are not employing or retaining or contracting with physicians who are on any of these lists. Then there are civil penalties and criminal prosecution, all of which needs to be considered.
SPEAKER_01It's also important to recognize that there are some other alternatives, other penalties that may be imposed that are not strictly by the book. And what I mean by that is
