Negotiate Contracts and Budgets In Clinical Trials
Summary
TLDRIn 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
- đ The speaker introduces a new product, an 'Introduction to Clinical Research' DVD, available for purchase on their blog.
- đ The DVD is designed for research clinics and is affordable compared to other training programs.
- đââïž The speaker addresses a question from a viewer about negotiating contracts and budgets in clinical trials.
- đŒ The speaker has 11 years of experience in coordinating clinical trials and is now involved in contract negotiations.
- đ The speaker plans to release a series of videos on contract and budget negotiations, including interviews with industry experts.
- đĄ The speaker emphasizes that sponsors expect negotiation on the initial budget proposal and encourages scrutinizing every line item.
- đ They discuss the possibility of negotiating increases on various budget items, such as study coordinator time and physician time.
- đ« The speaker mentions that some items, like participant payments, cannot be increased due to ethical considerations.
- đ The speaker suggests using public records from universities to model an overhead policy for negotiating purposes.
- đ Key points for contracts include indemnification clauses, payment terms, and provisions for study termination.
- đ 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
đ 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.
đŒ 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.
Mindmap
Keywords
đĄClinical Trials
đĄNegotiating
đĄContracts
đĄBudgets
đĄSponsor
đĄResearch Coordinators
đĄIndemnification Clause
đĄOverhead
đĄSunshine Act
đĄProfit
đĄDVD
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
Voir Plus de Vidéos Connexes
How To Get Better At Negotiating Clinical Trial Budgets and Contracts
Why Are Clinical Research Contracts and Budgets So Complicated For Clinical Research Sites?
How CROs and Sponsors Improve TMF Management with a Shared eTMF - Agatha eTMF software
Why Animals Are Needed in Research
Understanding 'Levels of Evidence' - What are Levels of Evidence?
What is a Trial Master File (TMF) Specialist?
5.0 / 5 (0 votes)