Negotiating Clinical Trial Agreements: Balancing the Interests of Sponsors and Healthcare Providers
Structuring Indemnification, Subject Injury, IP Rights, Data Rights, and Other Key Provisions
Recording of a 90-minute CLE video webinar with Q&A
This CLE course will review critical provisions in clinical trial agreements (CTAs), discuss variations in study site organizations and the potential impact on CTA signatories, outline best practices for structuring effective provisions and contracts, and guide healthcare counsel on handling the potential challenges in CTA negotiations.
Outline
- Challenges in negotiating a CTA
- Proper Parties
- Regulatory compliance
- Indemnification
- Subject injury
- Insurance
- IP ownership
- Key provisions to include in a CTA
- Compensation
- Data rights
- IP rights
- Publication
- Confidentiality
- Record retention
- Monitoring, audit, and FDA inspection
- Indemnification
- Subject injury
- Limitation of liability
- Insurance
- Use of name
- Termination
- Best practices for effective negotiation
Benefits
The panel will review these and other key issues:
- What are the significant stumbling blocks that can hinder the parties in negotiating a CTA?
- Why does it matter if you do not figure out the proper contracting parties?
- What scope of indemnification is appropriate?
- How do we draft a subject injury provision that protects both parties? Should insurance be billed first? What if the injury careprovider is not the research site?
- What CTA language is mandated by AAHRPP?
- What CTA provisions ensure that the trial sponsor owns the intellectual property created as a result of the clinical trial?
- Why do you need to review the informed consent form to ensure it is consistent with the CTA subject injury provision and the CTA budget?
Faculty
Amanda K. Coulter
Of Counsel
Coppersmith Brockelman
Ms. Coulter advises clients in the healthcare industry on clinical research matters. She has extensive experience... | Read More
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.
Close
Katherine Leibowitz
Co-Founder & Managing Member
Leibowitz Law
For almost 25 years, Ms. Leibowitz has worked with sponsors, service providers, technology vendors and sites on their... | Read More
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.
Close
Kate Duffy Mazan
Member
Clinical Technology Transfer Group
For the past 20 years Ms. Mazan has practiced exclusively in the area of food and drug law with an emphasis on the... | Read More
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.
Close