Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials?
What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients?
Should a Sponsor get access to patient data collected outside a clinical trial setting?
To answer these questions and more, I invited Darshan Kulkarni to the show.
Darshan is a regulatory attorney specializing in FDA law, professor, author, and speaker.
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.
He has led rare disease pharmaceutical companies in developing global programs to foster clinical trial transparency and enhance public health.
He serves on the editorial board for Applied Clinical Trials at Advanstar Communications serving as a legal advisor on the clinical trial industry.
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.
Last but not the least he is the host of the DarshanTalks livestream interviews where he discusses issues that impact the life science industry.
This podcast is brought to you by Florence Healthcare. More than 10,000 study sites, sponsors, and CROs in 44 countries trust them to accelerate their operations. To learn more, visit https://florencehc.com/