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
Don’t Let Your PI Walk Away With Your Study
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In this tactical masterclass, Darshan Kulkarni breaks down the critical legal architecture required to protect clinical trial sites during rapid expansion. As PIs and Sub-Investigators move between organizations, the risk of losing proprietary data and patient continuity skyrockets. Learn the specific clauses—from non-solicitation to transition requirements—that ensure your site retains its value and your sponsors remain confident. Don't let your most valuable assets walk out the door; learn how to lock down your contracts today.
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How do I keep PI and sub-I contracts straight so that they don't walk away with patients or data? This has been coming up for me more often as sites are spending more time expanding. Now your PI agreement should clearly outline obligations, whether we're talking about oversight, reporting, patient safety, delegation. Sub-investigator contracts must reinforce that data, patience, and study materials belong to the site and not the individual. Otherwise, sub-eyes and PIs can leave and take their patients with them. Include non-solicitation and confidentiality provisions, because this may or may not be enforceable within your state's law. You must see whether they are applicable. Spell out that any patient recruited under the trial is retained by the site even if the investigator departs. If possible, build in transition clauses that require cooperation during staff turnover. Strong PI and sub I agreements prevent data loss. They protect patient continuity, and they keep sponsors confident in your stability. Call, click, or email.