Darshan Kulkarni, PharmD, MS, JD is an attorney and advisor focused on clinical research compliance in the life sciences industry. He has over 15 years of experience guiding pharmaceutical, biotech, and medical device companies through the complex legal and regulatory frameworks that govern clinical trials. Darshan has taught and published extensively on research compliance, bioethics, and FDA regulatory issues, helping sponsors, CROs, and investigators navigate topics such as informed consent, fraud and abuse, site contracts, and investigator responsibilities. His work emphasizes proactive compliance strategies that reduce enforcement risk while enabling innovation.