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.

Outlines

00:00

📚 Launch of 'Introduction to Clinical Research' DVD

The speaker begins by welcoming the audience back to the 'Clinical Trials Guru' website and introduces a new product, an 'Introduction to Clinical Research' DVD. The DVD is designed for training purposes and is available for purchase on the first day. The speaker highlights a question from a customer who is new to negotiating contracts and budgets in clinical trials. The speaker promises to cover this topic in depth in future videos and on the DVD's bonus content, which includes interviews with industry experts like Anna Marquez. The speaker also emphasizes the importance of negotiating every line item in a budget, explaining that sponsors expect it and provides tips on how to approach negotiations, including the possibility of significant increases in reimbursement.

05:01

💼 Navigating Contract Negotiations and Budgets in Clinical Trials

In this paragraph, the speaker delves into the specifics of contract and budget negotiations for clinical trials. They mention the Sunshine Act as a potential leverage point for sponsors to negotiate costs down, advising the audience to be familiar with it. The speaker also discusses the importance of having documentation for overhead costs, suggesting looking at public records from universities as a model. Key points for contracts are highlighted, such as indemnification clauses to protect the principal investigator and specifying payment terms to avoid ambiguity. The speaker also touches on the sponsor's right to terminate studies and the importance of getting advance notice. The paragraph concludes with a call to action for the audience to check out the DVD and become a producer for the 'Clinical Trials Guru', offering a lifetime membership at a set price.

Keywords

💡Clinical Trials

Clinical trials are research studies that involve human participants to determine the safety and effectiveness of medical interventions. In the video, the speaker discusses the process of negotiating contracts and budgets for clinical trials, which is crucial for ensuring that the trials are conducted ethically and efficiently.

💡Negotiating

Negotiating in the context of the video refers to the process of discussing and coming to an agreement, particularly regarding the terms of contracts and budgets for clinical trials. The speaker emphasizes the importance of negotiating every line item in a budget to ensure profitability and feasibility.

💡Contracts

Contracts are legally binding agreements that outline the terms and conditions of a particular arrangement, such as the conduct of a clinical trial. The speaker mentions the importance of having an indemnification clause in contracts to protect the principal investigator and specifies payment terms.

💡Budgets

Budgets in the video refer to the financial plans for clinical trials, detailing the costs associated with various aspects of the trial. The speaker advises on how to negotiate these budgets, including increasing line items and ensuring that the study remains profitable after negotiations.

💡Sponsor

A sponsor in clinical trials is typically the organization funding the research. The script mentions that sponsors expect sites to negotiate the budgets they provide, indicating a common practice in the industry.

💡Research Coordinators

Research coordinators are professionals who manage the day-to-day activities of a clinical trial. The video is mentioned as a resource for these coordinators to review and for training new employees, highlighting the educational aspect of the content.

💡Indemnification Clause

An indemnification clause in a contract is a provision that protects a party (such as a principal investigator) from liability or loss. The speaker advises ensuring that contracts include such clauses to safeguard against potential legal issues arising from the trial.

💡Overhead

Overhead refers to the indirect costs of running a business or research site, such as rent and utilities. The speaker discusses the negotiation of overhead costs in clinical trial budgets and suggests looking at public records of universities for comparison.

💡Sunshine Act

The Sunshine Act is a U.S. federal law that requires certain financial relationships to be disclosed. The speaker mentions it as a potential leverage point for sponsors to negotiate costs down, indicating its relevance in the context of clinical trial negotiations.

💡Profit

Profit in the video refers to the financial gain or positive outcome that a clinical trial site aims to achieve after conducting a study. The speaker stresses the importance of negotiating budgets to ensure a profitable study, aligning with the business aspect of running a research site.

💡DVD

The DVD mentioned in the video is an educational product created by the speaker to introduce clinical research concepts. It is used as a training tool for research coordinators and new employees, and the speaker discusses its relevance to the topic of contracts and budgets.

Highlights

Introduction of a new product: an 'Introduction to Clinical Research' DVD by the speaker.

The DVD is designed for research coordinators and new employees for training purposes.

The speaker has 11 years of experience in coordinating clinical trials and is now involved in contract and budget negotiations.

The speaker emphasizes the importance of negotiating every line item in a clinical trial budget.

Sponsors expect an increase request in the budget and often provide an initial budget that accounts for negotiation.

The speaker has negotiated up to 100% increases on certain budget items in the past.

Some budget items, like participant payments, cannot be increased due to IRB regulations.

The speaker suggests using university overhead policies as a model for creating one's own policy.

Indemnification clauses in contracts are crucial to protect the Principal Investigator.

Payment terms should be clearly specified in contracts to avoid confusion.

Sponsors have the right to terminate studies, and contracts should reflect advance notice periods.

The Sunshine Act may be brought up during negotiations as a leverage point by sponsors.

Documentation for overhead costs is important and can be based on public records from universities.

The speaker plans to release more videos on the topic of contracts and budgets.

The DVD is available for purchase and is suitable for anyone new to clinical trials.

Call to action for potential producers to join the Clinical Trial Guru community.

The DVD launch date is February 11th, 2013.

Transcripts

hey everybody I want to welcome you back

to theclinical trials guru.com again

that website address for you is the

clinical trials guru.com and I love

getting questions and today's question I

actually got it's going to be a little

bit of a Shameless plug but I'm excited

to roll this product out it's my

introduction to clinical research DVD

and today's question I got from someone

who ordered the already ordered the DVD

and I'll keep this person's name

completely Anonymous uh not sure if they

would like their name all over the

internet but I appreciate you making the

purchase and emailing me I see that

several people purchased the DVD today

and the first day it's available uh so

Shameless plug go to my blog and check

out introduction to clinical research

DVD so anyways this person asks a good

question I've been coordinating clinical

trials for about 11 years and just

recently was given the job of negoti sh

in contracts and budgets I wanted to see

if you could give me any information

about this topic uh I have looked online

and I'm not finding a whole lot of info

there uh and then this person says I

also purchased this DVD for the purposes

of my research coordinators reviewing

this and any new employee that may come

along for training purposes so thank you

before I get into your question about

negotiating contracts and budgets um let

me just tell you that

this DVD is perfect for research clinics

I mean I don't care if you just buy one

and share it that's fine um this is what

I made this DVD for because there's

other training programs out there sure

but they're very costly and mine is I

feel it's at a good price point so

anyways check it out is today's the

first day that it's available uh okay so

about contracts and budgets so there's

several things believe it or not I'm

going to do a bunch of videos on this

and on the bonus on the bonus DVDs

included in the um in the DVD that

you'll get you'll see some interviews

some fantastic interviews with the Anna

Marquez and we talk about negotiating

contracts and budgets for like an hour

uh but just to keep this one very short

when you negotiate contracts and budgets

we're going to really break it down into

the budgets first and then the contracts

later and and for the contracts I'm

lucky have an attorney as a business

partner so I let him handle the

contracts as far as the language and the

the wordage but I'll talk about some key

points towards the end of this video but

let's focus first on the budget so when

you get the

budgets the most important thing you

want to understand is that the sponsor

expects you to ask for an increase okay

they don't just I mean they give you

that I'm sure some research sites just

accept it the way it is but they give it

to you with the price somewhat marked

down because they figure you're going to

be negotiating at least from my nine

years in this industry that's what I've

I've even heard this from monitors

before not that they would probably tell

you anymore but this is um I mean it's

common knowledge so when you get that

budget you want to really look and see

if you're able to do that at those costs

and you you definitely want to negotiate

every line item now sometimes you'll get

the budgets with the Excel sheets where

where they'll list every single

procedure and how much they'll reimburse

you and other times you'll just get how

much they'll pay you for each visit so

in either case I mean in the Excel sheet

you have more detail so you can pinpoint

exactly what you're going to increase in

price and some things you can't increase

such as how much you'll pay the study

participants um because the IRB can see

that as um coercion but the rest of the

stuff I mean study coordinator time

physician time uh study startup those

things you can negotiate and I've

negotiated 100% increases on these

things in the past I've even heard some

people do two and 300% increases but for

the most part if you can get 50%

increase to what they sent you

originally uh you're doing good you're

doing pretty good just make sure that

even after you negotiate that that it's

still a lucrative study for you and that

you can really not just break even but

actually make a profit because that's

what we're in business to do is actually

make a profit out of this that's what

the purpose of business is so make sure

you negotiate every single line item and

if they don't have line items for the

procedures you can either ask for one or

just increase the entire visit budget

and be prepared prepared to hear several

things in reply be prepared to hear

about the sunshine act that's um I've

actually interviewed Daran karney on the

show before he's a producer of the show

a friend of the show we talk extensively

about this I will link to it um but it's

basically uh it's not really intended

for research sites but it's a loophole

where we fall into it and it is another

leverage point for the sponsors to try

to negotiate our cost down so be

prepared to hear that be familiar with

it and be ready to negotiate and you may

also hear that uh they want some kind of

proof some kind of documentation

regarding your overhead your overhead um

for your site so if you get like a 10%

overhead you might want to ask for 30%

and there's nothing wrong with that but

be prepared to show some kind of

documentation so what I would do is look

at other research clinics in your area

or better yet because they're public

records universities in your area and

see what their overhead is and what

their overhead policy is these are all

public documents for the most part so

look up some of those just do some

Google searches for universities in your

area and as far as their overhead policy

for their research Department

specifically clinical research

department and then look at that and

kind of make one of your own as well you

can use that as a model I wouldn't just

totally um plagiarize it but use it as a

model and then build your own off of

there because you you are running a

business and you have overhead I mean

that's you definitely should have a

policy in place now when it comes to the

contracts there's certain things that

you want to make sure in there the first

one is an indemnification clause which

makes sure that your Pi is held harmless

if he or she follows the protocol should

someone in the study get injured or

harmed another thing is the payment days

make sure that it's specified in the

contract exactly when payments will be

expected at your site if it's 30 days

make sure that you they specify 30 days

after what is it 30 days after we enter

the data or is it 30 days after the

monitor reviews the data that we entered

because that can actually be 60 or 90

days so you want to make sure it's very

specific in there and also the sponsor

does have a right to terminate the study

at any time make sure you get at least

one or two

months um advance notice before they can

terminate a study from you you may not

always get that but it's always good to

ask for and it's always good to know at

least one or two months ahead of time if

the sponsor is planning on canceling the

study or terminating the study so hope

hopefully these things help I'm going to

do more videos on this so I'll put the

links to some of some interviews that

I've done in the past and that's hours

of content right there and I really hope

you enjoy the DVD let me know um how it

is and I talk a little bit about

contracts and budgets in there too but

it's at a very basic level uh for

coordinators or people who are brand new

to research to just learn the Core

Concepts of this I want to end by giving

my clinical trial Guru producers a shout

out that's Sarah Elizabeth seagler

resolve research Solutions accurate

clinical trials ER har clinical trials

ptnr Patrick Stone we have Daran karney

biofarm systems mosio zire South Coast

clinical trials and breakthrough

clinical trials and if you're interested

in being a producer it's 99 bucks for a

lifetime membership email me Dan

theclinical trials guru.com and I have a

few spots left I'm not going to accept

many more so move fast on this and also

check out the introduction to clinical

research DVD it's just available for

sale today February 11th

2013 it's perfect for anyone who's just

learning clinical trials hope this helps

Dan from the clinical trials guru.com