Negotiate Contracts and Budgets In Clinical Trials

Summary

In this video, the host of clinical trials guru.com introduces a new DVD on clinical research, perfect for training new coordinators. They address a question about contract and budget negotiation in clinical trials, emphasizing the importance of scrutinizing every budget line item and negotiating increases. The host shares insights on common industry practices, discusses the Sunshine Act's impact on negotiations, and highlights key contract clauses to watch for, such as indemnification and payment terms. The video promises further in-depth content on these topics.

Takeaways

• 📚 The speaker introduces a new product, an 'Introduction to Clinical Research' DVD, available for purchase on their blog.
• 🔍 The DVD is designed for research clinics and is affordable compared to other training programs.
• 🙋‍♂️ The speaker addresses a question from a viewer about negotiating contracts and budgets in clinical trials.
• 💼 The speaker has 11 years of experience in coordinating clinical trials and is now involved in contract negotiations.
• 📈 The speaker plans to release a series of videos on contract and budget negotiations, including interviews with industry experts.
• 💡 The speaker emphasizes that sponsors expect negotiation on the initial budget proposal and encourages scrutinizing every line item.
• 📊 They discuss the possibility of negotiating increases on various budget items, such as study coordinator time and physician time.
• 🚫 The speaker mentions that some items, like participant payments, cannot be increased due to ethical considerations.
• 📝 The speaker suggests using public records from universities to model an overhead policy for negotiating purposes.
• 📖 Key points for contracts include indemnification clauses, payment terms, and provisions for study termination.
• 🔗 The speaker mentions the Sunshine Act as a potential leverage point for sponsors during negotiations and advises being prepared to address it.

Q & A

What is the purpose of the 'Introduction to Clinical Research' DVD?

The 'Introduction to Clinical Research' DVD is designed to provide training for research coordinators and new employees in the field of clinical trials, covering core concepts and offering insights into various aspects of clinical research coordination.

Why is the speaker excited about the product launch of the DVD?

The speaker is excited because the DVD offers valuable training at a good price point compared to other costly training programs, and it is being well-received with several purchases on the first day of its availability.

What is the role of the person who asked the question in the script?

The person who asked the question has been coordinating clinical trials for about 11 years and has recently been given the responsibility of negotiating contracts and budgets.

Why did the person purchase the DVD?

The person purchased the DVD for their research coordinators to review and for training purposes for any new employees that may join their team.

What is the most important thing to understand when negotiating budgets according to the speaker?

The most important thing to understand is that sponsors expect you to negotiate for an increase; they provide an initial budget with the expectation that it will be negotiated upwards.

What is the general advice given for negotiating line items in a budget?

The advice is to negotiate every single line item, and if there are no line items for specific procedures, to increase the entire visit budget. It's also suggested to aim for at least a 50% increase from the original offer.

What is the Sunshine Act, and how does it relate to negotiating with sponsors?

The Sunshine Act is a regulation that is not intended for research sites but affects them indirectly. It is a leverage point for sponsors to negotiate costs down, and research sites should be familiar with it to be prepared for such negotiations.

Why is it important to have documentation for overhead costs when negotiating?

Documentation for overhead costs is important because sponsors may request proof of what is included in the overhead percentage requested by the research site. It helps validate the requested overhead rate.

What are some key points to consider when negotiating contracts?

Key points include ensuring an indemnification clause to protect the Principal Investigator, specifying payment terms, and securing advance notice in case the sponsor decides to terminate the study.

How can one prepare for negotiating overhead costs?

One can prepare by researching other research clinics or universities in the area to understand their overhead policies and use these as a model to create their own policy.

What is the speaker's suggestion for those interested in becoming a producer for the clinical trials guru.com?

The speaker suggests emailing them at theclinicaltrialsguru.com for a lifetime membership opportunity at $99, but notes that spots are limited and encourages interested parties to act quickly.