DarshanTalks Podcast
Welcome to DarshanTalks!
We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there!
Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do.
We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
Sponsor to Organization vs. Direct Investigator Agreements: Pros & Cons
Edye Edens from KLF highlights the key differences between sponsor-to-organization agreements and direct investigator agreements. Larger research organizations and academic medical centers often prefer sponsor-to-organization agreements because they provide structured negotiations around intellectual property (IP) rights, indirect costs, liability protections, and compliance oversight. These agreements also ensure that investigators have access to institutional resources and support.
On the other hand, direct investigator agreements may offer a faster turnaround, but they come with greater risks. Investigators negotiating independently might agree to terms that organizations would typically reject, potentially exposing themselves to legal and financial liabilities.
Understanding these distinctions is crucial for managing risk. While direct agreements may have their place, it’s essential to carefully evaluate the terms and ensure adequate protections. If you're unsure about the best approach for your situation, consult legal experts before signing. Need guidance? Get in touch with KLF.
