Why Are Clinical Research Contracts and Budgets So Complicated For Clinical Research Sites?

Summary

In this video, the speaker discusses the complexities of contracts and budgets in clinical trials, emphasizing the unique aspects of each study. They highlight the importance of overhead costs, such as administration and quality control, and how these can be negotiated with sponsors. The video also touches on the challenges of distinguishing between overhead, line items, and invoiceable costs, and the need for specialized knowledge to navigate these processes effectively. The speaker advocates for the use of networks like DSCS to streamline and democratize access to this information for sites of all sizes.

Takeaways

• 📝 Contracts and budgets are essential for clinical trial sites as they grow busier with more studies.
• 🤝 Special shout out to Chris, the business partner who handles contract and budget negotiations for Yuma Clinical Trials, a DSCS site.
• 🔍 The complexity of contracts and budgets comes from the uniqueness of each study and the various costs involved.
• 🏢 Overhead costs include administrative expenses, rent, payroll, and marketing efforts that benefit all studies.
• 🛡 Quality control and assurance systems are crucial for maintaining compliance with FDA regulations.
• 💻 Technology fees, such as eSource, can be part of the budget and may be passed on to sponsors.
• 📈 Recruitment costs, like those for advertising through platforms like Patient Ace, can be invoiced to sponsors.
• 🧊 Some costs like dry ice may be overhead, specific line items, or invoiceable pass-through costs depending on the study.
• 🍽 Patient meals and transportation are often invoiceable fees, but can also be considered overhead.
• 📈 Fair market value is important to understand for negotiating line items in contracts and budgets.
• 📚 Training costs for CRCs are part of doing business and can be negotiated into budgets for most studies.
• 🔄 Economies of scale and working with networks like DSCS can help streamline contract and budget negotiations.
• 🤖 Automation of certain aspects of contracts and budgets is possible, but the human element is still crucial for specialized knowledge and negotiations.

Q & A

What is the main topic discussed in the video script?

The main topic discussed in the video script is the complexities of contracts and budgets in clinical trials, particularly from the perspective of a clinical trial site.

Who is Chris Soer and what is his role in the context of the script?

Chris Soer is the business partner of the speaker and is responsible for negotiating all contracts for Yuma Clinical Trials, which is a DSCS site in the DSCS site network.

What does the term 'overhead' refer to in the context of clinical trials?

In the context of clinical trials, 'overhead' refers to the administrative costs such as rent, payroll, workers' compensation, branding, marketing, and community outreach, as well as quality control mechanisms and QA systems.

What is the significance of understanding the fair market value of procedures in clinical trials?

Understanding the fair market value of procedures is crucial because it helps in negotiating contracts and budgets accurately, ensuring that the site is adequately compensated for the services provided during a clinical trial.

How can a clinical trial site pass off certain costs to sponsors in a contract?

A clinical trial site can pass off certain costs to sponsors by including them as line items in the contract, such as eSource fees, technology fees, recruitment costs, and invoiceable pass-through costs like x-rays, MRIs, and local labs.

What is the role of Patient Ace in the context of the script?

Patient Ace is one of the speaker's other companies used for advertising on Instagram and Facebook. It is mentioned as a tool for recruitment in clinical trials, with the costs of the ads potentially being passed off to sponsors.

What is the difference between overhead costs and invoiceable costs in clinical trials?

Overhead costs are general operational expenses of the site that are not directly tied to a specific study, while invoiceable costs are specific expenses related to a study that can be billed directly to the sponsor.

Why is it important for a clinical trial site to have a quality management system?

A quality management system is important because it ensures that the site is following SOPs (Standard Operating Procedures) and is prepared for FDA audits, which are critical for maintaining compliance and credibility in clinical trials.

What is the role of a CRC (Clinical Research Coordinator) in a clinical trial site?

A CRC is responsible for coordinating the day-to-day activities of a clinical trial at a site. They ensure that the trial is conducted according to the protocol, and they may also be involved in training, which is an ongoing cost for the site.

What does the speaker mean by 'democratizing' contracts and budgets for clinical trial sites?

The speaker refers to making the process of contract and budget negotiations more accessible and understandable for smaller sites, possibly through the use of technology and support networks like DSCS, to level the playing field with larger sites and networks.

How can a smaller clinical trial site navigate the complexities of contracts and budgets without a network like DSCS?

A smaller site may need to learn the intricacies of contract and budget negotiations the hard way, possibly by hiring specialized knowledge like a contract negotiator or by gaining experience and understanding the industry standards and databases used by larger sites and CROs.

Outlines

00:00

📝 Understanding Contracts and Budgets in Clinical Trials

This paragraph discusses the complexities of contracts and budgets in clinical trials, emphasizing the unique aspects of each study. The speaker introduces Chris, a business partner who handles contract negotiations for their site, which is part of the DSCS network. The paragraph delves into overhead costs, such as administration, rent, payroll, and marketing, which are shared across all studies. It also touches on the importance of quality control and the potential for passing certain costs to sponsors, like eSource fees and recruitment expenses. The speaker highlights the challenge of distinguishing between overhead, line items, and invoiceable costs, using examples like dry ice, meals, and transportation for patients, and the necessity of having a 24-hour line for patient support.

05:01

💼 Navigating the Fair Market Value and Contract Negotiations

The second paragraph focuses on the importance of understanding fair market value for various procedures in clinical trials, as sponsors and CROs are likely to have detailed knowledge of these values. The speaker shares experiences where CROs have attempted to underpay based on incorrect fair market values. The paragraph underscores the challenges faced by smaller, independent sites that lack access to such databases and must learn through experience. It also discusses the necessity of training costs, such as CRC training fees, and how these can be negotiated into study budgets. The speaker mentions the potential for economies of scale and the benefits of working with a network like DSCS, which aims to streamline and democratize the process for sites of all sizes. The paragraph concludes with thoughts on the intricacies of contracts and budgets and an invitation for feedback on the topic.

Keywords

💡Contracts

Contracts in the context of the video refer to legal agreements between parties, typically a clinical trial site and a sponsor or CRO, outlining the terms and conditions of a clinical trial. They are crucial for defining responsibilities, expectations, and financial arrangements. In the script, the speaker mentions that every study has unique complexities, and contracts help manage these by specifying what costs and responsibilities each party will bear.

💡Budgets

Budgets are financial plans that allocate resources for various aspects of a clinical trial. They are essential for understanding and managing the costs associated with conducting research. The video emphasizes the intricacies of budgets in clinical trials, highlighting how they can include both fixed costs, like overhead, and variable costs, like specific study procedures.

💡Overhead

Overhead costs are indirect expenses associated with running a clinical trial site, such as rent, payroll, and administrative costs. These costs are not directly tied to a specific study but are necessary for the overall operation of the site. In the script, overhead is mentioned as a significant part of the budget that includes general administrative expenses and quality control mechanisms.

💡Quality Assurance (QA)

Quality Assurance in clinical trials involves processes and systems to ensure that trials are conducted, monitored, and reported according to good clinical practice standards. QA is vital for maintaining the integrity of the trial and is often a part of the overhead costs. The speaker mentions that QA systems are essential for compliance with FDA regulations during audits.

💡Sponsors

Sponsors are organizations that finance and initiate clinical trials. They are responsible for the overall design, management, and monitoring of the trials. In the video, sponsors are discussed in relation to their financial contributions to the trials and their role in contract negotiations, particularly regarding the costs of conducting trials.

💡CROs (Contract Research Organizations)

CROs are external agencies that provide support to sponsors in managing clinical trials. They act as intermediaries between sponsors and clinical trial sites, often having access to more detailed information about fair market value for various trial-related costs. The script mentions CROs as entities that might try to negotiate lower costs based on their knowledge of fair market values.

💡eSource

eSource refers to electronic data capture systems used in clinical trials to collect and manage data digitally. This technology can reduce the need for paper records and streamline data management. In the script, eSource is mentioned as a potential cost that can be negotiated into the contract and budget for a clinical trial.

💡Recruitment

Recruitment in clinical trials involves the process of identifying, enrolling, and retaining participants for a study. It is a critical aspect that can significantly impact the success of a trial. The video discusses recruitment as a cost that can be invoiced to sponsors, especially when using tools like Patient Ace for advertising.

💡Fair Market Value

Fair Market Value is the price at which an item or service would be exchanged between a willing buyer and a willing seller in an open and competitive market. In clinical trials, understanding the fair market value for various procedures and services is important for setting budgets and negotiating contracts. The script mentions the importance of knowing fair market values to avoid being underpaid by sponsors or CROs.

💡CRC (Clinical Research Coordinator)

A Clinical Research Coordinator is a professional responsible for the day-to-day management of clinical trials at a site. They ensure that trials are conducted according to protocols and regulations. The video discusses the importance of training CRCs and the costs associated with their training, which can be part of the overhead or negotiated into specific study budgets.

💡DSCS (Decentralized Site Network)

DSCS refers to a network of clinical trial sites that work together to streamline operations and share resources. The speaker mentions DSCS as an organization that helps sites, especially smaller ones, by providing support in managing contracts and budgets. This network aims to democratize access to knowledge and tools for clinical trial management.

Highlights

Introduction to the topic of contracts and budgets in clinical trials, emphasizing their complexity and uniqueness for each study.

Acknowledgment of business partner Chris Soer, who handles contract negotiations for Yuma Clinical Trials as a DSCS site.

Explanation of overhead costs, including administrative expenses, rent, payroll, and marketing.

Discussion of the importance of quality control mechanisms and QA systems for compliance with SOPs and FDA audits.

The concept of eSource fees and how they can be negotiated as part of the contract.

Introduction of technology fees and how they are being incorporated into budgets.

The role of Patient Ace in managing recruitment advertising and the process of invoicing sponsors for these costs.

Differentiating between overhead costs and invoiceable costs, such as dry ice, meals, and transportation for patients.

The challenge of determining when costs become overhead versus an invoiceable line item for a specific study.

The necessity of understanding fair market value for various procedures and the role of sponsors and CROs in this knowledge.

The economic considerations and negotiations involved in determining overhead versus line item costs.

The importance of economies of scale and the benefits of working with a network like DSCS.

The human element in contract and budget negotiations and the difficulty of automating this process.

The necessity for sites to understand what they will be paying for before conducting a study.

The role of CRC training and how it can be negotiated into budgets for reimbursement.

The ongoing responsibility of training employees, regardless of sponsor reimbursement.

The potential for smaller sites to join larger site networks or companies for support in contract and budget management.

The ongoing efforts of DSCS to streamline and democratize contract and budget processes for sites of all sizes.

Closing thoughts on the complexity of contracts and budgets and an invitation for further discussion on the topic.

Transcripts

Guru Nation thank you so much for

watching make sure you like subscribe

comment share really means a lot to me

today I want to talk a little bit about

contracts and budgets and like remove

some of the mystery around it so you

know we've most sites when they start

getting busy they start getting more and

more contracts and budgets and really

quick shout out to my business partner

Chris soer who negotiates all of our

contracts because Yuma clinical trials

is a dscs site in the dscs site Network

and Chris oversees all the contract and

budget negotiations so um I will I have

Chris on as a regular guest and we've

discussed these kind of things before

but I want to kind of to break it down

for you and show you the complexity of

contracts and budgets because every

study is unique every study has you

complexities and intricacies that only

that

study uh that are unique to that study

but the site in general has something of

what's called overhead which is admin

which is rent which is payroll workers

comp which are things like branding

marketing community outreach when we go

out and do branding it's not just for a

study it's for all of our studies uh

then we have other things that go into

overhead like you're supposed to have at

least quality control

mechanisms um QA systems in place making

sure that we are following our Sops

these are things that when the FDA comes

to audit you better have quality

management system yeah a lot of these

things we can pass off on to the

sponsors in the contract in budget for

example when you break when you break

down like quality insurance well do you

have a eSource okay how much is that

that could be part of the eSource fee

you could have overall technology fee

which we've started putting into some of

our budgets so you can get little pieces

of things here and there you can

definitely get a recruitment invoiceable

added to your budget when it comes to um

advertising like we use patient Ace

which is one of my other companies for

Instagram and Facebook ads and we can

pass those invoices off to the sponsors

but we can also pay our monthly fee to

Patient Ace right just for a bundle of

studies and then we got to break it down

based on the ads and which ones I be

approved and which one goes to which

sponsor so at one point does it become

overhead versus an invoiceable and it

gets complicated because I would would

use patient Ace even if I lost one of my

studies I would use patient Ace even if

I lost two of my studies I don't think I

would use patient Ace if I lost all my

studies there would be no need I don't

have studies but the point is I'm using

the tool regardless of any one

particular trial it's a technology that

my site chooses to pay for with or

without study

XYZ and so there's a lot of economic

considerations in place

when you break down what's overhead

versus what's a line item for a

particular study versus invoiceable pass

through costs like um x-rays MRIs local

Labs not every study's going to want or

need those things but for the ones that

do you better make sure that you are you

have that in your invoiceable cost for

that sponsor another element is dry ice

um sometimes that's just part of

overhead other times it's a specific

align item that you've got an invoice

for other times you have things like

meals for patients or transportation for

patients like a lot of the times those

are invoiceable fees and the meals

because the patients already receive a

stipend you're not going to get

necessarily meal reimbursement for your

patients because the sponsor the sponsor

may ask you well why are they getting a

study participant fee but then you just

want to be a nice company and have a

pleasant and and offer snacks for your

patients so that then becomes part of

overhead so these are a lot of moving

Parts having that 24hour line for

patients to call non-stop like there's a

real human being answering that phone

that's part of overhead so overhead gets

a lot of the overhead is a lot of the

catch all bucket but then every study

also has line items for certain

procedures and each of those procedures

have their own range of fair market

value and you have to know what that

fair market value is because believe me

the sponsors and cro know that stuff and

they probably have a database especially

the C have a database for that stuff and

the cro also have access to this

information more so than the sponsors

because they are the middle men between

sponsors and sites a lot more than

sponsors have access to the data so as a

site you've got a lot of headwinds

working against you and according to

Chris my business partner like and I've

been a witness to this we've caught C's

lying to try to save a buck based on

fair market value with the same sponsor

now luckily for us again this is

economies of scale and the benefit of

working with we won't let them play

those games but if you're a smaller site

and you're independent and you're not

using a service like the SCS you've

going to you're just going to have to

learn this stuff the hard way and that's

where the human element comes in to

where there's there's no real way to

automate the contract and budget aspect

yet there's ways to automate certain

aspects of it but to automate the fine

nuances and the specific negotiations

that go into a budget or a contract you

need highly specialized knowledge like

someone like Chris ber someone like like

Daran K Carney and then you have to

understand what you're actually going to

be paying for before doing a study so

again there's certain costs of doing

business CRC training but there then you

get a CRC training fee if you know how

to negotiate it in every budget for most

studies again if you ask for it but that

should also be part of your ongoing

program as a site like you have

employees you're expected to train those

employees whether a sponsor is paying

for it or not so if you don't have a

study and you have a CRC do you mean to

tell me you're not training him or her

because you didn't get your CRC training

fee yet no that's a cost of doing

business so a lot of times you can get

your cost reimbursed from different

buckets and at the end of the day it

kind of all pays for itself if you're

doing it right it kind of all takes care

of itself and allows for decent profit

for the site owner ERS uh and you reach

a point where training a CRC is not just

makes them a viable CRC for one study

but for many studies at which point now

you can afford quality assurance person

to come in or maybe one of your other

crc's or you hire a quality assurance

person to do the QA which is not a line

item in any budget that I've seen

although I'm sure we can start asking

for those and as with all things in this

indry if you can justify it you you'll

get it but typically QA is part of the

overall site business model like you're

supposed to watch for your quality

assurance as a site owner so it gets

complex and this is why a lot of sites

reach out for help and we're here to

help you so dscs is the site Network

we're here to help uh we are working on

ways to streamline these things and

we're working on ways to democratize

this for the sites for the smaller sites

the bigger sites and the bigger site

networks you kind of almost forced if

you're a small site to join forces with

a bigger site Network or at least a

company like DS eventually it's going to

reach the masses with technology we're

not there yet but we're working on it

but just my thoughts on contracts and

budgets and uh why it's so complicated

like subscribe comment share let me know

if you want to hear more on this topic

byebye