7 Types of Clinical Trial Agreements - The Essential Guide | Istvan Fekete

Описание: In this episode we shed light on the intricacies of various types of clinical trial agreements. Through a comprehensive discussion, we provide valuable insights into the nuances of negotiation, risk assessment, and the unique characteristics of different trial types. From industry-sponsored trials to investigator-initiated studies, the conversation delves into the role, challenges, and considerations associated with each type of agreement.

Types of Clinical Trial Agreements Explored:
1. Industry-Sponsored Trials,
2. Phase Four and Post-Market Studies,
3. Registry Studies,
4. Federally Funded Studies,
5. Drug and Device Studies,
6. Consortium Studies,
7. Investigator-Initiated Studies:

Navigating Complexities and Compliance:
Throughout the conversation, Istvan Fekete and Darshan Kulkarni emphasize the importance of compliance, risk assessment, and ethical considerations in clinical trial agreement negotiations. They touch upon the potential risks of seeding trials and highlight the need for both sponsors and sites to be vigilant about potential fraud and compliance issues.

Takeaways and Concluding Thoughts:
Istvan Fekete shares practical advice for both sponsors and sites, encouraging proactive feasibility assessments and streamlined concurrent negotiations. The conversation underscores the multifaceted nature of clinical trial agreements, underscoring their pivotal role in advancing medical research while ensuring ethical practices and efficient collaborations.

Join our discussion between Darshan Kulkarni and Istvan Fekete.

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Website: https://www.darshantalks.com/
Law Firm: https://kulkarnilawfirm.com/
Twitter:   / darshantalks  
LinkedIn:   / darshankulkarni  


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Disclaimers:
This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relationship