DarshanTalks Podcast
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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 Legal Risks of AI Sponsor Protocols
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Is AI the savior of clinical research costs, or a ticking time bomb for data integrity? In this episode, Darshan Kulkarni dives into the murky waters of AI-driven sponsor protocols. We explore how AI is being used to mask—and unmask—data falsification, and what life science sponsors must do to ensure compliance before the regulators knock. If you’re using AI to "make life easier," you might be making your legal defense much harder.
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I'm seeing sites go in there and get sponsor protocols, upload them into um tools that are available, and then saying, okay, we've got these tools, we're uploading this data, um, it's gonna make my life easier. Well, you might have problems. The big thing that you have to consider is that AI is now cutting costs. The question is, how are you going to use it at your site? How are you going to ensure that if you're a sponsor, you're using these tools to address compliance, to address issues with data falsification, all of which can be checked using AI. So I have a whole presentation on AI and clinical research. I just gave that a couple of days ago. But feel free to reach out and I'm happy to talk through it with you.
