Joint Healthcare/Clinical Research (Virtual) Forum - 261118

"New CTA Paradigms: Strengthening Sponsor Agreements Amid PE Consolidation"
presented by Darshan Kulkarni, Kulkarni Law Firm

The PMI Atlanta Healthcare and Clinical Research Forums are joining forces this month! Everyone is welcome to participate. This joint session offers the opportunity to cross-network among both forums' attendees.  

Presentation

Why it is time to tear up your current Clinical Trial Agreement and start fresh.

This presentation is best suited for clinical trial sponsors, legal counsel, clinical operations leaders, and trial contract negotiators navigating the legal complexities introduced by private equity (PE) consolidation in clinical research.

The talk focuses on evaluating legal and operational risks within Clinical Trial Agreements (CTAs), specifically focusing on Corporate Practice of Medicine (CPOM) regulations across various states, state-level scopes of practice, site insurance coverage limits, intellectual property (IP) exposure from third-party site tools or AI, and protocol continuity during study terminations.

Key Takeaways: 

• Identify PE & CPOM Exposure: Sponsors must look past site names to verify true entity ownership, management services organization (MSO) structures, and state-level CPOM restrictions (such as in Texas, California, and New York).
• Enforce Scope of Practice Rules: Ensure non-physician staff (e.g., Clinical Research Coordinators or Medical Assistants) are not unlawfully performing clinical tasks or dispensing investigational products.
• Audit Insurance & Verify Local Coverage: Regularly audit site insurance policies to ensure coverage extends beyond basic parent company indemnification and covers local trial activities.
• Protect IP Against Site Vendors & AI: Safeguard study data against third-party electronic data capture (EDC) platforms or AI tools that attempt to claim worldwide licenses or derivative rights.
• Plan for Termination & PI Transitions: Structure CTAs to clearly define data ownership, protocol rights, and trial continuity when PIs depart or terminate their site relationships.

Biography

Darshan Kulkarni, PharmD, MS, Esq., is a regulatory attorney and pharmacist specializing in FDA law, clinical research, and corporate strategy. As Principal Attorney at the Kulkarni Law Firm, he advises pharmaceutical, biotech, and medical device sponsors on Clinical Trial Agreements (CTAs), regulatory compliance, and trial operations.

Dr. Kulkarni brings a unique multi-disciplinary perspective as an Instructor in Law at Drexel University, Chair of the Board for the Emily Whitehead Foundation (EWF), and host of the DarshanTalks podcast.

He frequently speaks on emerging legal risks in clinical trials, including discussions on private equity consolidation, Corporate Practice of Medicine (CPOM) regulations, scope of practice issues, AI integration, and intellectual property protection in research agreements.

When

Wednesday, November 18, 2026, 6:00 PM - 7:15 PM

Where

Microsoft Teams Meeting

Fees

PMI Atlanta Member: $10.00
Non-Member: $12.00

Meeting content, presenter, and location are subject to change. Refunds will not be made for changes in meeting content, presenters, or locations. 

PDUs

Earn 1 PDU
Talent Triangle Category: Business Acumen