Katherine Leibowitz has supported clinical trials for over 25 years, advising across the lifecycle —from study start-up to data rights, specimens, secondary research, tech enablement, and commercialization, including information-security risk. She co-founded Leibowitz Law in 2013 after spending 17 years at a top global law firm. Katherine’s practice emphasizes clinical research, AI, digital health, and primary/secondary data and specimen use, and “big 4” risk allocation:  subject injury, indemnification, limitation of liability and insurance.  

She handles the full clinical trials contracting process – CTAs, budgets, HIPAA, informed consent, EDC and eTMF vendor agreements, CRO MSAs, and more.  In a landscape of decentralized trials, AI, cyber risk and biobanking, Katherine modernizes contract templates and negotiations to keep deals moving efficiently. 

A frequent speaker and author, Katherine integrates regulatory, legal, technological and industry perspectives to guide the life sciences community.