Negotiating Clinical Trial Agreements: Balancing the Interests of Sponsors and Healthcare Providers
Structuring Indemnification, IP Rights, Confidentiality and Other Key Provisions
Recording of a 90-minute CLE webinar with Q&A
This CLE webinar will provide guidance for healthcare counsel on handling the potential challenges in clinical trial agreement (CTA) negotiations, review key provisions in CTAs, and outline best practices for structuring effective provisions and agreements.
- Challenges in negotiating a CTA
- Key provisions to include in a CTA
- Principal investigator
- IP rights
- Record retention
- Patient injury compensation
- Best practices for effective negotiation
The panel will review these and other key questions:
- What are the significant stumbling blocks that can hinder the parties in negotiating a CTA?
- What steps should counsel take to prevent wholesale publication of the study results and limit publication of the trial data?
- What CTA provisions ensure that the trial sponsor owns any intellectual property created as a result of the clinical trial? What scope of assignment would be acceptable to all parties?
Geoffrey M. Raux
Foley & Lardner
Mr. Raux represents a variety of clients in the business and health care sectors. His practice concentrates on... | Read More
Mr. Raux represents a variety of clients in the business and health care sectors. His practice concentrates on complex commercial litigation matters, internal investigations, and government compliance.Close
Julie Rusczek, Esq.
Drinker Biddle & Reath
Ms. Rusczek focuses her practice on research compliance issues, representing institutions, pharmaceutical and device... | Read More
Ms. Rusczek focuses her practice on research compliance issues, representing institutions, pharmaceutical and device companies, and other entities on matters such as developing research review policies, ensuring adequate protections for human research subjects, reviewing contracts for various research arrangements, and providing advice regarding compliance with privacy laws. She also represents hospitals, health systems and long-term care providers on a wide range of health law issues including medical staff matters, informed consent, patient confidentiality, reimbursement, and fraud and abuse.Close