This one is for all the doctors and medical specialists who are interested in opening up their own research clinic. As a doctor who’s interested in this option, we imagine that you’ve already seen a clinical research environment either by participating as a sub-investigator or a PI (principal investigator). If this is the case and you’re already familiar with everything that clinical research entails, then you’re in a good position to start your own clinical research center or research clinic.

1. Essentials for Setting up a
New Clinical Research Center

2. Introduction
This one is for all the doctors and medical specialists who are interested in
opening up their own research clinic.
As a doctor who’s interested in this option, we imagine that you’ve already seen a
clinical research environment either by participating as a sub-investigator or a PI
(principal investigator). If this is the case and you’re already familiar with
everything that clinical research entails, then you’re in a good position to start
your own clinical research center or research clinic.
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3. First of all, just like any other business, in clinical
research you should also start small and grow
step by step. This means that you can start
clinical research in your own private practice.
After a while, if you see that you’re successful
and everything is going well, you can choose if
you want to enlarge your clinic or open up a new
one.
How to Start?

4. 4
Essentials for Setting Up
a Research Clinic
If you own a private practice with a lot of patients in your database, then
opening your own research clinic is an excellent idea. The essentials for
opening a research clinic can differ based on your budget, so here we’ll
only give you the minimum requirements necessary for the beginning. All
of these requirements are based on conducting 5 to 10 studies a year in
your clinic.

5. Your Hospital
5
Essentials for Setting Up a Research Clinic
The first and most necessary thing you’ll need is an
exam room for the patients who enroll in the trials.
We are putting this as a separate point because
usually, your regular exam room for all your other
patients isn’t a good fit for the study subjects,
especially if you have a busy clinic. So, having an
extra exam room is a must in this case!
EXAM ROOM
You are probably already sitting in this room! Since
you are going to be the owner of this research
clinic, we suppose that you will be the PI or the
Principal Investigator. If so, then you’ll need an
office for yourself, and this can be the office that
you already use for your private practice.
PI ROOM

6. Your Hospital
6
Essentials for Setting Up a Research Clinic
Since most of the tasks in a trial are delegated to
coordinators, you will need to provide them with a
coordinators’ office where they can work.
Coordinators are some of the most overworked
people during a trial, so it’s impossible for them to
work without an office. Make sure that the office
you prepare for coordinators is only for them, and
not a common office with monitors coming in for
visits.
COORDINATORS ROOM
Another important office space that you’ll need is
the room for monitors. Always try to make a
separate room only for when monitors come in, so
that you avoid situations when the monitors find
documents or papers they aren’t supposed to. For
example, if a monitor comes for a visit in the middle
of a busy day, the coordinators’ office will usually
be a mess, so if you settle the monitors in the same
office, they can find many more things to complain
about. This is why having a clean monitor-only
room is important for every research clinic or
clinical research center.
MONITORS ROOM
Different rooms for
CRCs and CRAs!!!

7. Your Hospital
7
Essentials for Setting Up a Research Clinic
If you have the budget for it, try to have a separate
IP room that will be locked, with limited access, no
traffic, and with controlled temperature. In reality,
the minimum requirement is an IP cabinet.
However, placing this cabinet in a room where
unauthorized staff and patients walk through is
risky and can cause you many problems with the
FDA, the sponsor, and the monitors. If you aren’t
able to afford to have a separate IP room, then
make sure to place the IP cabinet somewhere
where patients won’t have access to it. And
remember, the IP cabinet also has to be double
locked and with controlled temperature.
IP ROOM / IP CABINET
Yet another thing you’ll need in your clinic is a
centrifuge and a fridge. These are needed both for
the investigational drug (IP) as well as for blood
and other specimens that will have to be kept and
processed throughout the trial.
CENTRIFUGE AND FRIDGE

8. Your Hospital
8
Essentials for Setting Up a Research Clinic
A common mistake that many clinics make is
underestimating how much space source and regulatory
documents can take. There are thousands of documents
involved in a single protocol, so make sure that your
research center has enough room to store all these
important documents.
PHYSICAL SPACE FOR
DOCUMENTATION STORAGE
Most clinics will usually need to have a lab where they
can draw blood, process it (once you have a waiver as
a permission), and ship the results. In the past, ECG
machines were usually provided by the sponsor, but
nowadays, it’s expected that sites have their own ECG
machines available for study participants.
LABORATORY AND ECG

9. Your Hospital
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Essentials for Setting Up a Research Clinic
As we’ve mentioned many times before, clinical trials
are complex and they require a lot of correspondence
with vendors, patients, staff, sponsor, etc. For this
reason, it’s practically impossible to work without a fax
machine and internet connection. On top of that, most
sites are slowly transferring completely online these
days, in clouds and virtual workspaces, and they start
using EDC systems, CTMS, etc. All of these things are
extremely important, so having a good connection is a
must!
FAX AND INTERNET
Last but not least, you’ll need time! Even though as
a PI you’ll be able to delegate most of your tasks to
other site staff such as coordinators, you’ll still need
to realize that clinical research does require time.
At the beginning, until you get used to everything
and learn things, you can try giving half of your time
to clinical research and the other half to your
private practice. Later on, when things are running
smoothly with the trial, you can probably delegate
more of your responsibilities. Like this, you’ll have
more time to dedicate to your private practice while
still enjoying the benefits of doing research
TIME

10. www.trialjoin.com
CONCLUSION
Above, we’ve given you 10 things that can serve you as a checklist of the minimum requirements essential for setting up a new clinical
research center. Even though it might seem complicated at the beginning, if you have a busy private practice and a large patient pool
then this is probably the perfect thing for you to do.
Aside from the medical advancements that you’ll be a part of, clinical trials are also lucrative, so the benefits of opening a research clinic
are definitely worth the risks.
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