As a clinical research site trying to get a better budget for a study, you need to remember that every item of a budget is negotiable. Being a good negotiator will allow you to get more out of every study you conduct at your site. In this article, we’ll teach you how to reach a win-win negotiation, as well as remind you of some of the most commonly neglected items in clinical trial budgets. Negotiating a budget is usually a long process and there are going to be many disagreements until you finally reach a mutually-beneficial deal, so continue reading and learning in order to achieve your goals and conduct a profitable study.

1. Negotiating Clinical Research Budgets:
Most Commonly Neglected Items

2. Introduction
As a clinical research site trying to get a better budget for a study, you need to
remember that every item of a budget is negotiable.
Being a good negotiator will allow you to get more out of every study you conduct
at your site.
In this article, we’ll teach you how to reach a win-win negotiation, as well as
remind you of some of the most commonly neglected items in clinical trial
budgets.
Negotiating a budget is usually a long process and there are going to be many
disagreements until you finally reach a mutually-beneficial deal, so continue
reading and learning in order to achieve your goals and conduct a profitable study.
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3. Reach a Win-Win Outcome
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A negotiation between you as a site
and the sponsor can bring several
different outcomes. These outcomes
can be seen as:
Win-Win
Win-Lose
Lose-Lose
Of course, the ideal outcome would be win-
win. This is an outcome that meets the goals
and targets of both parties, so it's mutually
satisfying and beneficial. The win-win
outcome is what every good negotiator will
aim to achieve. The win-lose outcome
means that one party is satisfied with the
agreement while the other isn’t. And finally,
the lose-lose scenario tells us that both
parties are losing instead of winning, and
this usually happens when they cannot find
common ground.

4. 4
Find a middle compromise or find
a creative solution
Realizing this fact as soon as possible
will spare you many unnecessary
surprises during the negotiation
process. You must understand that your
goals won't always fit with the other
party's goals. Being equipped with this
knowledge will help you to navigate
your expectations and the negotiation
process more easily.
Acknowledge that the goals of the
other party aren't the same as yours
How to Reach a Win-Win Outcome?
The best strategy for reaching an ideal
win-win outcome is trying to find a
compromise in the middle. However, in
some situations, this is impossible for
many different reasons. In this case, the
next step you should try to do is think of
a creative solution that can help bring a
win-win outcome. If also this doesn't
work, then remember that you have the
right to decide if you want to accept or
decline a study!

5. 5
Don't assume but learn
Focusing on only one issue in a
negotiation agreement will bring
negative consequences for one or both
parties. When a negotiation revolves
around just prices and money for
example – all the other aspects are
ignored and not discussed enough. Try
to make time to discuss every aspect of
the agreement in order to improve the
results for both parties.
Don't get stuck on one aspect
How to Reach a Win-Win Outcome?
You can never know your client's goals
and needs in advance, even if you think
you do. Assuming and guessing what
they want is a common mistake that
needs to be avoided. Instead, try to
learn and understand their goals and
needs so that you're able to provide
them with a better offer that will fit
their needs and targets.

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Most Commonly Neglected
Budget Items
This second part of our article will give you 5 things that many sites tend to
forget to include in their budget agreements.
Even though they might seem like small things at first, they will actually add up
to much more than you initially expected. For this reason, it’s important that
you include these items in your budget and get properly reimbursed for them.
After all, you don’t want to work at a loss.

7. 1. Fees for Archiving
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storage time storage space storage protection storage security
The archiving or storage fee has to be included in your initial budget. Depending on the
type of trial and sponsor you’re dealing with, study records will have to be archived and
kept safe anywhere from 5 to 30 years. And a trial can have a lot of records and
documents. Storing these documents for such a long time requires space, protection, and
security measures, and all these things cost money. By remembering to include the fees
for archiving in your budget, you’ll make sure from the beginning that you’ll be
reimbursed.

8. 2. Fees for Protocol Amendments
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As expected, no protocol is perfect at the beginning. There’s always going
to be something that needs to be changed, and this is why protocol
amendments exist as a necessary concept. Calculating fees for numerous
protocol amendments is yet another budget item that sites often forget to
include. Protocol amendments can be expensive, so being reimbursed for
such events is a must! In order to calculate and make an estimation of
these fees, you can either use your own past experience on similar studies
or bill the sponsor immediately after the protocol amendment with
invoices and proofs of all costs. Regardless of how you wish to charge for
this, you need to discuss it with the sponsor and include these fees in the
budget agreement.

9. 3. Fees for Patient Transportation
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Most sites offer transportation services for their patients. Whether
it’s a designated driver, a taxi service, an Uber, or even just
reimbursing the patients for their travel costs, all of these things will
add up in your total study budget. This is especially important for
sites who have patients other than locals. In order to be able to get
properly reimbursed for these transportation fees, always keep all
bills and invoices. Then, send all these receipts to the sponsor, either
monthly or twice a year, depending on how busy your site is.

10. 4. Start-Up Costs
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Even though it seems obvious, many sites
forget to include the start-up fees in their
budget. Doing this is absolutely necessary in
order to be able to organize everything and
start as smoothly as possible. The start-up
costs and the preparation for the trial are
always something that has to be covered by
the sponsor. Examples of such fees include:
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1 PI training and meeting time;
Coordinator training;
Protocol training;
Staff training on all necessary things;
EDC training;
Protocol review time;
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11. 5. Costs for Dry Ice
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Even though it seems obvious, many sites
forget to include the start-up fees in their
budget. Doing this is absolutely necessary in
order to be able to organize everything and
start as smoothly as possible. The start-up
costs and the preparation for the trial are
always something that has to be covered by
the sponsor. Examples of such fees include:

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CONCLUSION
Negotiating a budget that works for both sides (a win-win outcome) can sometimes be a long process which requires you to
remember many small but important details. On top of that, the sponsor usually won’t agree immediately to everything you
suggest, of course, because nobody wants to pay more than necessary. The best way to get the sponsor to agree on a budget item
is to provide them with the right justification such as numbers, previous experiences with similar budget items, etc. Everything
that’s written and official as a proof will serve more than just empty words.
We hope that the tips we gave you above can help you reach a budget agreement that fits both you and your sponsor. And finally,
don’t forget to include these 5 crucial things in your budget plan. By following these tips, you’ll manage to work with a profit, and
this is something that every research site aims to accomplish.
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