In the clinical research industry, sponsors are the ones who fund every trial. These sponsors or CROs can be pharma or bio companies which invest large amounts of money for conducting research. Sponsors will typically choose one or multiple research sites, depending on the size of the study and the required number of enrolled participants. One of the biggest concerns of all clinical research sites is being selected to conduct a study. Usually, after interested sites place a bid on a certain study, the sponsor will send a feasibility questionnaire to the sites he or she is interested in. After the sites fill out this feasibility report, the sponsor will choose one or multiple sites and go on a site selection visit. The site selection visit is the last step before you’re officially given the study to conduct. For this reason, sites should be especially attentive, make sure that everything goes as planned on these visits, and ensure that everything that the sponsor is going to see at the site fits the feasibility questionnaire they filled out earlier. The site selection visit is basically a confirmation that what you’ve stated in the questionnaire is actually true in practice. However, no matter how much sites try to take care of every detail, sometimes the sponsor will still find an objection. When this happens, sites need to learn how to handle it properly and give the right answers.

1. Resolving Sponsors’
Objections in Clinical Trials

2. Introduction
In the clinical research industry, sponsors are the ones who fund every trial.
These sponsors or CROs can be pharma or bio companies which invest large
amounts of money for conducting research.
Sponsors will typically choose one or multiple research sites, depending on the
size of the study and the required number of enrolled participants. One of the
biggest concerns of all clinical research sites is being selected to conduct a
study. Usually, after interested sites place a bid on a certain study, the sponsor
will send a feasibility questionnaire to the sites he or she is interested in. After
the sites fill out this feasibility report, the sponsor will choose one or multiple
sites and go on a site selection visit. The site selection visit is the last step
before you’re officially given the study to conduct. For this reason, sites should
be especially attentive, make sure that everything goes as planned on these
visits, and ensure that everything that the sponsor is going to see at the site fits
the feasibility questionnaire they filled out earlier. The site selection visit is
basically a confirmation that what you’ve stated in the questionnaire is actually
true in practice.
However, no matter how much sites try to take care of every detail, sometimes
the sponsor will still find an objection. When this happens, sites need to learn
how to handle it properly and give the right answers. 2

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Sites Place Bids on
the Sponsor’s Study
Sponsor Chooses
Potential Sites
Sponsor Sends Feasibility
Questionnaires to Sites
Sponsor Chooses a Site
and Goes on a Site
Selection Visit
Site Gets the Study
(if everything goes well)

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Most Common
Sponsors’ Objections

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PI Oversight
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The first and most common sponsors’ objection is definitely related to PI oversight! Many
times, even if your feasibility questionnaire states differently, sponsors have their ways of
finding out the type of PI your site has. In most cases, if your PI lacks oversight, the
sponsor will find out! If this is the problem you’re facing, then you need to learn how to
resolve it.
One of the most important things to remember here is to not go any deeper in your lie!
By this we mean to not create or open up additional problems by saying too much! Stick
to short and concise answers, and avoid entering other topics of conversation where the
sponsor might see yet another problem.
If the sponsor’s objection is PI oversight, the best thing to say as an answer is that your PI
is always there when needed and in the rare cases when he might not be there you
always have sub-Is to replace him. Reassure the sponsor that there is always a medical
professional at the site, at any given time, so that the patients are always in good hands.

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Good Clinical Practice (GCP)
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Record-Keeping Rules
Overall Standards of
Conducting Research
Defining the Roles of
Sponsors, Investigators,
and CRAs
Ethical Guidelines
Patient Safety and Well-
Being / Protection of Human
Participants
Staff Training Rules.
Working in accordance with Good
Clinical Practice is another important
field where sponsors might find an
objection. Overall, GCP exists to
determine the standards of
conducting clinical research, by
defining the roles of sponsors,
investigators, and monitors (CRAs).
As we can see, GCP is composed of
many different areas which can all be
a reason for a sponsor’s objection. No
matter the type of problem that
arises, GCP standards and guidelines
have to be followed and respected.

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Recruitment Objections
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Another really common type of sponsor objections is
recruitment. For example, if most sites in the area
have stated that they will be able to recruit 100
patients, and your site promises to recruit 200, the
sponsor will notice this big difference. In this case,
they will ask you how you’re planning to recruit so
many patients. When you’re asked a recruitment-
related question such as this, you have to explain to
the sponsor which are your recruitment strategies
and tactics.
Alarm: Huge difference in recruitment
site x
site y
site z
your
site

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Recruitment Objections
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Usually, the best thing you can tell the sponsor in this situation is that
the patients will come from your own PI’s database. Sponsors respect
sites and PIs who have large databases of potential patients that fit
the inclusion-exclusion criteria for the study. If this is the case with
your site, you will have a huge advantage! If not, the sponsor will need
to hear about all other recruitment strategies that you’re planning to
use, and how successful have these strategies been in the past. If you
can show them that you’ve had great recruitment results in the past,
then there will be no problem.
When we’re on the subject of recruitment, the sponsor can
sometimes choose many sites in the same area. If this is the case,
they might ask you how you’re planning to handle duplicate patients.
Again, the best answer here would be if your PI has his/her own
database with patients. Finally, remember to always maximize your
strengths and minimize your weaknesses!
Patients from your PI’s database
Other realistic recruitment plans
Past records of successful recruitment
Established ways of dealing with
duplicate patients
Minimizing weaknesses and maximizing
strengths

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Other Objections
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monitoring of
the study
proper delegation
of duties
record keeping of
important documents
safety of study
participants
Above, we spoke about three of the
most common types of objections that
sponsors might have for your site.
Aside from those, there are many
other smaller objections that you
might face, such as delegation of
duties, safety of study participants,
monitoring of the study, etc. For all of
these objections or generally any type
of objections you might encounter, the
best is to always stick to yes or no
answers (where applicable), or to the
shortest answers possible. The
purpose of this is to not raise any
other unnecessary questions that
might put you into even more trouble.

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CONCLUSION
As a final note, remember - short and concise answers, and focusing on your strengths while minimizing
your weaknesses. This is the best way to resolve any objections from your sponsor!
Thank you for your attention!
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