This talk will delve into the intricate legal and regulatory considerations that must be navigated when preparing to sell a clinical trial site. From understanding the legal obligations and compliance with FDA regulations, DOJ and OIG considerations, to managing contracts and intellectual property rights, this talk will provide a comprehensive overview. Participants will gain insights into the best practices for due diligence, risk assessment, and strategic planning to ensure a smooth and legally sound transaction.   Whether you are a site owner, legal counsel, or a stakeholder in the clinical research industry, this talk will equip you with the essential knowledge and tools to approach the sale of a clinical trial site with confidence.

Three Key Takeaways:  

1. Understanding Regulatory Compliance: Learn about the specific FDA regulations, ethical considerations, and international guidelines that govern the sale of clinical trial sites. Understand how to maintain compliance and avoid potential legal pitfalls.  
2. Navigating Contracts and Intellectual Property Rights: Explore the complexities of contracts, agreements, and intellectual property rights involved in the sale. Gain insights into how to manage these aspects effectively to protect the interests of all parties involved.  
3. Strategic Planning and Risk Management: Discover the importance of thorough due diligence, risk assessment, and strategic planning in the sale process. Learn practical strategies to identify and mitigate risks, ensuring a successful and legally secure transaction.   This talk is designed to provide a clear roadmap for those involved in the sale of clinical trial sites, highlighting the legal intricacies and regulatory requirements that must be carefully considered.