Clinical Research Data Transparency with Darshan Kulkarni

<p><span style="font-weight: 400;">Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials?</span></p> <p><span style="font-weight: 400;">What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients?</span></p> <p><span style="font-weight: 400;">Should a Sponsor get access to patient data collected outside a clinical trial setting?</span></p> <p><span style="font-weight: 400;">To answer these questions and more, I invited Darshan Kulkarni to the show.</span></p> <p><span style="font-weight: 400;">Darshan is a regulatory attorney specializing in FDA law, professor, author, and speaker.</span></p> <p><span style="font-weight: 400;">He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice.</span></p> <p><span style="font-weight: 400;">He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health.</span></p> <p><span style="font-weight: 400;">He serves on the editorial board for Applied Clinical Trials at Advanstar Communications serving as a legal advisor on the clinical trial industry. </span></p> <p><span style="font-weight: 400;">Previously, Darshan was on the editorial board of cosmetics and personal products for FDAnews where guided the publication with his clinical trial and pharmaceutical expertise.</span></p> <p><span style="font-weight: 400;">Last but not the least he is the host of the DarshanTalks livestream interviews where he discusses issues that impact the life science industry.</span></p> <p>This podcast is brought to you by Florence Healthcare. The learn more, please visit florencehc.com</p> <p> </p>