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 structure and 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.
- Challenges in negotiating a CTA
- Proper signatories
- Regulatory compliance
- Subject injury
- IP ownership
- Key provisions to include in a CTA
- Data rights
- IP rights
- Record retention
- Monitoring, audit, and FDA inspection
- Subject injury
- Limitation of liability
- Use of name
- Best practices for effective negotiation
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? What is a commercialization indemnity? What does it mean to indemnify for use of study data and results?
- How do we draft a subject injury provision that protects both parties? Should insurance be billed first? What if the provider is not the research institution?
- What human subject protection 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? What scope of assignment would be acceptable to all parties?
- What language do you need to review to make sure the informed consent form is consistent with the CTA subject injury provision and the CTA budget?
- Do sponsors need the right to copy and remove PHI from the study site?
Amanda K. Coulter
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
Co-Founder, Head of Legal Services
Ms. Leibowitz’s technology practice includes life sciences transactional work for companies seeking to develop,... | Read More
Ms. Leibowitz’s technology practice includes life sciences transactional work for companies seeking to develop, test and commercialize their FDA-regulated devices, drugs and biologics in the United States and internationally. She has developed a niche practice area encompassing the legal, regulatory and business aspects of medical device clinical research, trial start-up and study management, with a particular focus on clinical trial agreements and related trial documents, FDA financial disclosure, informed consent, subject injury, HIPAA, fraud and abuse, EDC database development and access, intellectual property, privacy and risk management issues for FDA-regulated companies. Ms. Leibowitz provides companies with a cross-disciplinary approach to transactions by addressing general contract law, FDA regulatory compliance, intellectual property, technology licensing, fraud and abuse, HIPAA, privacy, litigation risk management, and domestic and foreign legal and regulatory compliance.Close
Kate Duffy Mazan
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