Negotiating Clinical Trial Agreements: Balancing the Interests of Sponsors and Healthcare Providers

For almost 25 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.

Ms. Coulter advises clients in the healthcare industry on clinical research matters. She has extensive experience developing research compliance policies and processes, template forms, and template agreements. She assists clients by reviewing and negotiating confidentiality agreements, data use agreements, business associate agreements, federal grants and subcontracts, and industry-sponsored clinical trial agreements.

Before her work at Coppersmith Brockelman, she was Associate Director of the Sponsored Projects office at the University of Michigan, where she trained and managed a team of contract negotiators and research administrators dedicated to clinical research contracts and grants. She also developed, coordinated and administered training on research contracts, financial award management, grant administration, and compliance to physicians, clinical research coordinators, and research administrators. 

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.