Got Studies?

A Quick Guide to
Help You Get
Clinical Research
Studies
Got Studies? A Quick Guide to Help
You Get Clinical Research Studies
This guide will provide you with strategies and resources to find
support for your clinical research. It is divided into three parts,
which tackle the preparation of materials and necessary
documents to apply for funding, using the aide of investigative
sites, and actively attracting financial support by adhering to the
principles of the Business Development (BD) paradigm.

If you are reading this, you may be venturing into opening your
own clinical research site, or you might already have one (or
several); but need a sponsor to give you a chance on a study, or
maybe youre looking to attract more studies. In this guide we
will cover the steps needed to help you accomplish this goal. Just
to make sure that we are on the same page, lets discuss what
clinical research is.

A Short Definition. Clinical research is testing done on human

subjects, for the purposes of finding effective treatment options
for diseases and conditions and further prevention of their
incidence. While the idea of testing may sound simple, the
process of clinical research is quite complex. Clinical research is
multifaceted and can be overwhelming, especially for those who
are not committed to addressing the fields never ending 2
demands and needs. There are many aspects to be considered
 Got Studies? A Quick Guide to Help You Get Clinical
Research Studies
Many people do not understand that clinical research is a business- a big, booming business; especially if the
right study and the right sponsor are coupled. We have been in the industry a long time, and have witnessed
everything it can offer- the good, the bad, and the ugly.
The Good. The Bad
When sponsors trust you, youre Break the trust of the sponsor, or
bound to climb the research ladder. those involved in the research process
Sooner than later, you will find and youll find yourself in deep
yourself receiving more studies. trouble. Problems with ethics,
conflicts of interest, financial
transparency issues and
communication concerns are some of
the things that could harm you and
your clinical research site.
The Ugly
Anything that could go bad can also
get ugly. Imagine the potential legal
battles involved for any scientific
misconduct you may find yourself
accused of. They wont only drain your
energy, they will also drain your
pockets!
We are not saying that clinical
research is a money-making machine
with fickle people managing it. Rather,
the point is that because clinical
research has numerous benefits,
support for it is bountiful. To avoid
adverse events, or at least reduce the
possibility of them occurring, you
need to know what you are doing. You
can do this by preparing everything 3
Part 1. The Starting Point: Finding
Sponsors and preparation:
There is no way for you to conduct a study unless you have the
necessary education and resources, or people with the education
and resources to carry out your plan. The list below gives you the
minimum requirements to conduct clinical research.

The Protocol is Your Bible. You must adhere to the

protocol for the study! Why? Well, if you were in the middle
of data collection for your study, wouldnt you want to be
sure you were about to take the correct next step? Wouldnt
you want to make sure that you are moving in the right
direction? Of course you would. The protocol makes that
possible for you.

The Doctor is in. The Principal Investigator of any clinical

study should be a physician or an individual with an
equivalent degree. Aside from the degree, this person needs
the right training and experience in the field to be
considered as the PI. This is essential because it is the PI
who shoulders the responsibility of ensuring that the study
adheres to ethical standards and that it follows the protocol. 4
Part 1. The Starting Point: Finding Sponsors and Preparation

Hire a Coordinator! A study needs a coordinator as much as it needs a Principal Investigator. This
person is responsible for coordinating with other members of the team and also monitors the
research process. The coordinator reports to the principle investigator whenever there are concerns
regarding the study. Ideally, hire a nurse as your coordinator, their medical knowledge can be
beneficial in clinical research. Make sure your coordinator is quick, organized, and warm and
pleasant towards other people.

Identify your Institutional Review Board (IRB). Your IRB ensures that you are adhering to ethical
standards. They will assure patients that your priority is keeping them safe from adverse events
throughout the duration of the research. Here are a few to check out:
Solutions IRB
IntegReview IRB
Salus IRB
Sterling IRB
Copernicus IRB
Schulman IRB
Chesapeake IRB

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Part 1. The Starting Point: Finding Sponsors and Preparation

The Research Team. This includes everyone else who will be doing the research with you,
or for you, depending on what your role is. These individuals, like the PI, also need to be
equipped with the correct training, skills and knowledge for the study to be successful.

People are Important. Patient retention is more important than ever. Patients should feel
taken care of from the moment they step through your door. Be sure that you are working
with staff who understand this. It is difficult enough getting a patient randomized into your
trial, so you want to make sure patients have no reason to drop out.

Hello? How may I help you? You need a phone number that individuals, stakeholders, and
your potential sponsor can reach. Make sure to get a business phone line to make it easier
for them to contact you and your team.

Its about Time You Get a Building. Maybe buying a building is an exaggerated move.
However, make sure that you have a research facility for your study. If you still have not
Sponsors place their studies and money with sites that are professional, organized, ethical, and successful at
secured your HQ, then at least develop a plan for it.
patient recruiting and retention. Keep this in mind when developing a plan of action.

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 Part II. What a Site to See! Finding
Sponsors by Selecting and Navigating
Sites:
When you read the following, remember a key point: Where you find sites, you find
sponsors. Remember earlier when we mentioned clinical research as a business?
Investigative sites have a demand for studies. Where there are studies there is
revenue. With so many sites operating, what differentiates the successful, revenue
generating sites from the ones that are struggling to keep their doors open? Lets
explore some factors:

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 Part II. What a Site to See! Finding Sponsors by Selecting and
Navigating Sites
The assistance of websites.
Online resources like
ClinicalTrials.gov or
TrialJoin.com list clinical
research studies currently
underway. Although these
websites are made for
volunteers who wish to Turn to Social Media. Social
participate in studies, you can media has become a primary
use them to determine where means of communication in our
study sites are located and society. Why not take advantage
what companies are of it for your clinical research?
with concurrent studies in your area, you can go to clinicaltrials.gov,
sponsoring them.searchFor for LinkedIn has targeted ads which
studies and then click on the map. It will yield a visual
instance, if you wantclinical
picture of where to you can use for just about
research is being conducted. If you explore the siteconduct
a little more, you will
a study on renalalso see
anything- including clinical
a list of clinical studies done by condition. The list also
disease, but dont want of
indicates the status to studies. Create accounts for all of
these studies. If you click any of them, it will give you details
compete about the study as
these social networks and connect
well as the most important information that you need- including the company
them to one another to promote
sponsoring the study.
your clinical research. You are
Some researchers also register with existing online site-listing services (e.g. likely to find someone who works
CenterWatch, ClinalTrialGPS or TrialJoin) to put information about their study in the with a sponsor involved in clinical
database of these services. You can do the same for your study. Besides research that may find interest in
TrialJoin.com, many of these online listing services are not free. The use of these your posts or advertisements.
listing services can very quickly deplete your advertising budget. Also consider Interact with these people and you 8
 Part II. What a Site to See! Finding Sponsors by
Selecting and Navigating Sites
Network, Network, NETWORK! Certainly, many
of your colleagues are involved in clinical research.
You may have met them at medical forums,
conventions, conferences and maybe press
releases. Approach them and their clinical research
associate (CRA) and ask if they are still recruiting
sites for their studies. Consider recommending
sites youre aware of that support the studys
indication. A recommendation may come back to
you down the line. Use caution when making site
recommendations. You dont want to recommend
a site that is bogged down with dozens of other
studies, or a site that doesnt consistently meet
Spread the Word! Word of mouth follows the
same mechanics as networking, and is a great way
to discover new sites. People who tell you about
sites and sponsors involved in their studies are
those with whom you may have already built a
trusting relationship with (e.g. your mentor, a co-
investigator in a previous study, or even a family
member who is interested in the same field). The
information they give you will typically be reliable
and accurate.
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Part II. What a Site to See! Finding Sponsors by Selecting
and Navigating Sites

Hire a Study Broker. Study brokers are

Location, Location, Location!
The geographic location of a
boutique, a restaurant, or a club
can make or break the business .
The same is true with clinical
research sites. Sponsors prefer a
convenient location which their
representative can visit for a
feasibility review. If possible,
choose a site that is conveniently
located to freeways, major
highways, or near well known
landmarks. A site that is located
near restaurants or local
entertainment venues can often
be reason enough for a sponsor
representative or monitor to visit
experienced in finding studies based on your
sites capabilities. Be aware that tudy brokers
typically charge fees or commissions for their
services. For example, some study brokers will
charge a 10% commission for each study they
find you. On a typical study can be as much as
$20,000 to $40,000. This can get quite
expensive, considering your site may be working
on two or more studies referred by the study
broker. Brokers can be helpful resource for a
research site but, you might end up spending
more than expected.
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Part III. Finding Studies through the Business
Development

What is Business
Development (BD)?

Business Development
comprises a number of tasks
and is generally aimed at
developing and implementing
growth opportunities within a
company. A systematic business
development program increases
the probability of securing the
studies needed to keep a site in
business and growing. Much of
the buzz around Business
Development is focused on how
sites can attract clinical
researchers and sponsors. These
ideas can be beneficial to clinical
researchers who are in the
market to find a studys sponsor. 11
 Part III. Finding Studies through the Business
Development
First BD emphasizes having a clear understanding
of clinical research opportunities. Sites must be
aware of what they can offer and what cant offer. As Third Research sites should know the
a clinical researcher, you also must be aware of your answer to this question: Why should we hire
strengths and limitations as these will potentially you instead of another site? Why should
define your research parameters. You cannot sponsors give you studies instead of another
promise your prospective sponsor that you can work clinical researcher? As our first point
on studies you dont have a patient base for. This is emphasized- it is beneficial to know both
not part of your capacity as a researcher. You may
your strengths and weaknesses.
generate results for them, but they may not be
favorable based on the protocol.

Second Sites should understand the inner workings of sponsors

and clinical research organizations (CROs). Imagine securing an
appointment with a sponsor just to find out that you dont
understand their goals for the particular study. You would
certainly want to avoid this potential disaster at all costs.

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 Part III. Finding Studies through the Business
Development
Business Development has five steps, all of which share the equal importance. In order they are: generating leads,
qualifying prospects, evaluating study and sponsor partnership feasibility, developing your sales pitch, and
building and maintaining relationships with sponsors.
Generating Leads
Do not limit yourself to finding sponsors during the startup
phase of your clinical research. While you certainly need
their assistance at the start of the study, you may need to
start seeking out additional sponsors towards data
collection time and during data analysis. To generate
sponsor leads, you can use two approaches - one is akin to
retail marketing and the other is a bit more interactive. In
retail marketing, you would post ads or content online
about your clinical research and then wait for sponsors to
find and reach out to you. The key idea here is waiting
the way stores wait for customers to visit them and
purchase an item or two. In the second approach, you
would engage in more active strategies. For example, you
would research, call, and email pharmaceutical companies
and CROs directly to follow up on your status. Just make
sure though that you do not become a pest when doing a
follow up. Make sure you time your communication
correctly- not too soon but not too late and not too frequent
Qualifying Prospects
Now, its time to talk to the right people and
turn your leads into possible sponsors. The
challenge is finding the decision maker or,
sometimes more importantly, simply finding
an individual who can provide you with the
decision maker's name, phone number, and
email address. Be patient and try to identify
who you should be talking to. Do your best to
gain in-depth knowledge about the agency to
ensure you are communicating with the right
individuals. In addition, when communicating,
be warm and friendly- first impressions are
everything.
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 Evaluating Study and
Sponsor Partnership
Feasibility
Once you have found the right people to
open a line of communication with, its time
to evaluate if you and the prospective
sponsor are a good match. Aside from the
common goal of completing the study, what
other values do you share? This is important
to consider as you may be be working with
the sponsor for a long time to come. You
would not want them to suddenly withdraw
their support because of discord between
you and the company.
To illustrate: Maybe you value and appreciate
transparency from all parties involved during
the stages of your research. You may find out
that the sponsor is secretive with the
information they are willing to share with
you. Considering how opposite being
secretive is to being transparent, weigh the
consequences of entering into a working
relationship with this company first before
proceeding to the next step. Regret comes
later, and in clinical research you should not
wait for it to come knocking on your door.
Developing Your Sales
Pitch
What do you have to offer? Develop a
sales process that presents your
credentials as a clinical researcher and
illustrates your success. Have your
portfolio ready in case the company asks
for it. Create presentations of your
previous work. If you have the resources,
conduct a webinar with them. Now is the
time to make your mentor and your
colleagues proud. Take care to not be
overly boastful when presenting what
you can offer to the sponsor. Keep in
mind that sponsors follow specific criteria
when selecting clinical sites to support
their studies. Depending on their
evaluation of you and what you can offer,
they may or may not contact you. In the
event that they reject you for this phase
of the study, do not fret. There are many
other phases and different drugs in the
pipeline or indications that you can
engage in.
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 Building and Maintaining Relationships with
Sponsors
When you land a funding agency, be sure to build and maintain a good
relationship with them. Sincerity and openness to constructive feedback are
key elements in building a relationship with your sponsor. Sure, you are good
and sure you can produce clinically significant results; but there will always be
room for improvement. Show gratitude by keeping in contact with your
sponsors CRAs and other study contacts by sending them a token of thanks
perhaps a card during the holidays or a factsheet or newsletter acknowledging
their support. You will pave the way for future opportunities with your sponsor
if you nurture your working relationship with them.

If you keep the Business Development paradigm in your mind and apply its
key concepts, you will find the perfect sponsor.

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 In conclusion, I would like to
point out that across the concepts and
the strategies discussed in this guide,
perseverance is the theme.
Perseverance in life often creates
successful outcomes. The same
applies to clinical research effort
pays and it can pay big time.

I hope this guide has helped

you identify some beneficial strategies.
In the process of reading, you may
have brainstormed a grand, innovative
technique that could land you the
sponsor of your dreams! So that the
next time a colleague or another
clinical researcher would ask you, Got
studies? you can confidently say, As
a matter of fact, I do.

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