Clinical Trial Agreement Negotiation – Everything Your Lawyers Want You to Know – Part II

Are you interested to learn more about clinical trial agreements and what clinical trial attorneys would love you to know?

Compliance Concerns

Building from the previous session on the infrastructure of clinical trial agreements, our speakers focused on critical regulatory issues that can impact the trial’s legality. It covered: 

• Medicare Billing (False Claims; Secondary Payor Rule)
• Anti-Kickback Statute and the Personal Services Safe Harbor (Fair Market Value; Impact on Amendments; Services related to Intellectual Property)
• Privacy

Now that you’ve established the framework for the clinical trial agreement, gain understanding in other areas that typically cause anxieties.

Upon completion of this continuing education program, participants should be able to:

• Understand the essential elements of a clinical trial agreement.
• Gain an understanding of differing sponsor and site objectives in contracting.
• Offer alternative negotiated language to meet the needs of both parties.

Did you miss the first session? Watch the replay now.

Speakers:

• Molly G. Huggins, JD, MHA, Partner, Huggins & Zuiker, LLP
• Erin Shaughnessy Zuiker, JD, MPH, Partner, Huggins & Zuiker, LLP

Note: Each webinar in the series requires separate enrollment; while attendees are encouraged to register for all three sessions, it is not required.

Approved for 1.0 ACRP Contact Hours | Expires January 22, 2027