About the Course
Introduction
This CLE webinar will examine how life sciences and research counsel can adapt clinical trial agreements (CTAs) to address the expanding use of artificial intelligence in trial administration and operations. The panel will discuss how to draft and negotiate AI-specific CTA provisions and clauses impacted by AI, such as confidentiality, data sharing and use, restrictions on training and model improvement, and more. The panel will also address key due diligence considerations when evaluating AI vendors and systems and coordinating AI provisions with core CTA terms.
Description
Artificial intelligence is infiltrating the healthcare industry, changing how companies are doing business, including managing clinical trials. Traditional CTAs were not drafted with AI-driven workflows in mind, such as AI scribes, EHR integrations, protocol and informed consent summaries, translations, subject recruitment, or eligibility screening. Counsel must now anticipate unique legal, regulatory, and operational risks and ensure that AI usage is governed contractually.
Counsel should understand how to draft and negotiate AI-specific CTA provisions addressing confidentiality, data sharing and use, and restrictions on training and model improvement, as well as cybersecurity, HIPAA and privacy law compliance, and internal and vendor guardrails governing AI use. The discussion will explore risk allocation through representations, warranties, indemnification, and limitation of liability, emphasizing AI's impact on multiple CTA provisions in addition to standalone AI clauses.
The panel will also present practical due diligence strategies for evaluating AI vendors and systems, coordinating AI provisions with core CTA terms and related vendor and contractor agreements, common drafting pitfalls, emerging negotiation positions, and real world risk scenarios.
Listen as our expert panel examines how the use of AI is impacting CTA negotiation and drafting. The panel will discuss important due diligence considerations, key provisions to be included in the CTA, and pitfalls to avoid.
Presented By
Mr. Fekete is a nationally recognized expert in research contract negotiations, clinical trial operations, and the application of artificial intelligence to research administration. He brings more than 13 years of experience spanning higher education, consulting, managed services, and collaboration with academic medical centers, hospitals, nonprofit consortia, and the pharmaceutical industry. Mr. Fekete currently serves as a Principal at Attain Partners, where he leads practice development for research contracting and clinical operations. In this role, he has built and scaled a rapidly growing team, developed internal workflow and billing tools, and helped organizations design technology roadmaps that incorporate AI to improve contracting efficiency, risk assessment, and decision-making. His work includes advising clients on AI adoption for contract negotiation, clinical trial revenue optimization, and operational redesign. Mr. Fekete is a frequent speaker and published author, addressing topics including virtual research administration, collaboration in research operations, and patient control over biological samples.
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.
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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Date + Time
- event
Friday, May 15, 2026
- schedule
1:00 p.m. ET./10:00 a.m. PT
I. Introduction
A. Use of AI in clinical trials administration and operations
B. The impact of AI on CTAs generally
II. Key AI-related terms in CTAs
A. AI-specific clauses
B. Clauses impacted by AI
1. Confidentiality
2. Data sharing and use
3. Cybersecurity, HIPAA, and privacy considerations
4. Representations, warranties, and risk allocation
III. Best practices
A. Internal and external AI guardrails
B. Vendor agreements and relationship to CTA
IV. Negotiation and drafting strategies; pitfalls to avoid
V. Key takeaways
The panel will review these and other important considerations:
- What impact has AI had on CTA negotiation and drafting?
- What AI-related provisions should be included in the CTA? Why?
- What key additional AI issues should counsel consider before drafting the CTA?
Related Courses
AI Clauses in Clinical Trial Agreements: Drafting and Negotiation Strategies; Due Diligence; Pitfalls to Avoid
Friday, May 15, 2026
1:00 p.m. ET./10:00 a.m. PT
