Challenges in Negotiating Clinical Trial Agreements: Research Rights, Privacy, Risk Allocation, and AI

Ms. Kvedar practices in the firm’s U.S. healthcare and European life sciences groups, with a focus on both U.S.-based and cross-border regulatory compliance matters. She regularly advises healthcare and life sciences clients on data privacy and clinical research requirements, government investigations, and regulatory compliance obligations under state, federal, and international law. Ms. Kvedar advises clients on cross-border transactions and regulatory compliance matters spanning the United States, the European Union, the United Kingdom, Oceania, and Asia; U.S.-based clients on the application of the European Union’s General Data Protection Regulation to their research and health care operations; clients on healthcare-related investigations conducted by the New York State Attorney General and other government agencies; healthcare organizations regarding compliance with HIPAA and state data privacy laws, federal and state fraud and abuse laws, telehealth regulations, and state data breach notification requirements; and clients during healthcare transactions in the medical device, physical therapy, women’s health, clinical research, pharmaceutical, and health care software industries.

For nearly 30 years, Ms. Leibowitz has worked with sponsors, service providers, technology vendors and sites on their clinical trials, addressing FDA regulatory compliance, fraud and abuse, intellectual property, data rights, HIPAA, privacy, general contract law, industry trends and litigation risk management. Her clinical research practice focuses on CTA and budget negotiations, subject injury, informed consent, HIPAA, reimbursement, insurance, CRO MSAs, core lab services, financial disclosure, Sunshine Act, DSMB/CEC, consulting agreements, software and data licensing and development, EDC and website terms of use. Ms. Leibowitz also provides broad support to technology and digital health companies, including clickwraps, sales agreements, BAAs, privacy, consumer protection, artificial intelligence and guidance on website operations and business matters. Before co-founding Leibowitz Law, she spent 17 years at Hogan Lovells.

For the past 20 years Ms. Mazan has practiced exclusively in the area of food and drug law with an emphasis on the regulation of clinical research. In private practice she has assisted a variety of companies and institutions in complying with federal and state laws and regulations governing the conduct of clinical trials. Ms. Mazan has extensive experience in the negotiation of clinical trial agreements and the regulatory review of clinical research practices. Prior to entering private practice, she worked for nine years at the National Cancer Institute (NCI) within the National Institutes of Health. As a technology transfer professional at NIH she managed the intellectual property portfolio of NCI’s Natural Products Branch, negotiating CRADAs and international agreements with countries in Africa, Central and South America, and the Pacific rim. Ms. Mazan also worked with scientists from several other institutes within NIH to develop a wide range of technology.