Clinical research is a difficult and challenging business. Its complex nature can sometimes result in unpredictable problems, especially with poor management. A clinical research site is the basic and most important institution in the research business. It’s the site’s job to conduct the research in the best way possible and produce quality data. However, managing a clinical research site can also be challenging, and this is especially true for new sites. Poor site management can lead to losing credibility, losing the trust of sponsors, unnecessary waste of time and money, loss of data quality and integrity, a decrease of future studies, etc. In order to avoid all of these problems and gain a competitive advantage in this industry, you will have to learn how to properly manage your site.

1. How to Use Technology
to Improve Your Clinical Research
Site

2. Introduction
Clinical research is a difficult and challenging business. Its complex
nature can sometimes result in unpredictable problems, especially with
poor management. A clinical research site is the basic and most
important institution in the research business. It’s the site’s job to
conduct the research in the best way possible and produce quality data.
However, managing a clinical research site can also be challenging, and
this is especially true for new sites. Poor site management can lead to
losing credibility, losing the trust of sponsors, unnecessary waste of time
and money, loss of data quality and integrity, a decrease of future
studies, etc. In order to avoid all of these problems and gain a
competitive advantage in this industry, you will have to learn how to
properly manage your site.
Nowadays, the number of clinical trials is constantly increasing, and so is
the number of research sites. With so many sites to choose from,
sponsors have a lot of different options in front of them. For this reason,
you have to make your site stand out and be better than the others!
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3. www.trialjoin.com
So, the question remains -
HOW CAN YOU IMPROVE YOUR CLINICAL RESEARCH SITE?
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The use of technology for improving the management of a
clinical research site has been growing constantly, and it’s
expected to continue in that direction even more and faster
from this year on. When we talk about technology in clinical
research, we think of many different tools, software, and
platforms that are used for many different functions in a trial.
Depending on the size and complexity of your site, some
technologies will work good for you, while others won’t serve
you at all.
Below, we’ll tell you everything you need to know about using
technology at your site, which tools are good to use and
which aren’t, and teach you how to best implement
technological tools in order to reach a competitive advantage.

4. Clinical Trial Management System (CTMS)
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A CTMS or a clinical trial
management system is a
software that’s used in bio
and pharma industries as a
help in managing clinical
trials.
One of the best features of a
CTMS is its centralization,
which means that all of the
site’s operational data will
be stored and organized in
one centralized location
that can be easily accessed.
When choosing a CTMS for your
site, the most important thing is
to choose the right one! Every site
is different and has different
strengths and weaknesses. By
figuring out the weaknesses of
your site, you will find out which
features you need from a CTMS!

5. Clinical Trial Management System (CTMS)
www.trialjoin.com
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Financial and
Budget
Management;
Business
Development;
Subject Visits
Management;
Recruitment
tactics, budgets,
and outcomes;
Patient
Recruitment and
Retention;
Compliance
with
regulations;
CTMS

6. Electronic Data Capture (EDC) System
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An EDC system is another great piece of
technology that will allow you to collect
and organize your clinical research data
in electronic format. These EDC systems
have many benefits when compared to
traditional paper-based systems of
collecting data, so implementing such a
system at your site will definitely give
you some competitive advantage.
Nowadays, many EDC systems are actually
incorporated or integrated together with a CTMS.
An EDC system will improve the overall
functionality of your clinical research by providing
help and support in areas where traditional
methods are lacking. This system will help you save
time and resources that would have been
otherwise wasted on trivial tasks, and allow you to
focus your efforts elsewhere. When it comes to
clinical trials, a system that’s 21 CFR part 11
compliant is important! Some examples of such
EDCs are Medrio and Castor EDC.

7. Electronic Data Capture (EDC) System
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EDC
Designing eCRFs
Data entry
Managing queries
Audit trail
User permissions
Cloud-hosted
Export of data

8. www.trialjoin.com
Virtual Workspace
By using a virtual workspace platform, sites can upload their
files and documents online and organize them better. These
files can then be accessed by everyone who has permission to
do so. A virtual workspace will give you the opportunity to have
all files uploaded in one area, so you won’t have to email
everyone separately and be afraid that you forgot to send an
important file to someone.
However, even though these virtual workspace platforms
sound good in theory, they will mostly benefit larger sites, site
organizations, networks, or owners of multiple sites. Using a
virtual workspace is necessary only for more complex and
large organizations which possess large amounts of data and
files, so a small or a new site will probably not see many
benefits from such platforms.
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Automated Systems for Following Up on Leads
Even though these automated systems can exist as a part
of a larger CTMS, their importance is of crucial value for a
clinical research site, so we have to mention them as a
separate technological tool.
These automated systems can use emails, calls or text
messages that will be automatically sent to potential
leads that you’ve previously entered in the system’s
database. When we say ‘leads’ we refer to the potential
patients whom you’ve managed to find through referrals,
ads, websites, etc. The role of this automated system is
to follow up on these leads by sending them reminders
and constant updates of recruiting trials.
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Automated Systems for Following Up on Leads
These systems are usually a part of the services
that many recruitment companies offer to sites
and/or sponsors and CROs. Even though patient
recruitment still remains one of the most difficult
areas in clinical research, especially when it
comes to more complex trial protocols, a
recruitment company that uses these automated
reminder systems can be of great help for sites
and sponsors.
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11. Fingerprint Systems
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Some clinical research sites decide to use fingerprint systems
such as clinicalRSVP in order to avoid duplicate participants.
However, such a system can be expensive, and it will only work if
other sites in the same study are using it, so that you’re able to
cross-reference patients from all sites. For this reason, having a
fingerprint system is not one of the most necessary and
important things in a trial.
Instead of spending money on a fingerprint system, a much
simpler and cheaper way to check for duplicate participants
would be to write down the participant’s initials and date of birth
and then ask the sponsor to check if this participant is already
enrolled at another site for the same study. Like this, you will
save money and still ensure that you’re not enrolling the same
participant at more than one site.

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CONCLUSION
As we can see, there are many ways to use technology in order to gain advantage as a clinical research site. While the use of
the above technological tools can give you some competitive advantage and superiority, remember that technology isn’t
everything. You should see these tools only as an extra helping hand in your research, not as tools that can replace human
and manual work. There are areas in research that cannot be replaced by technology and still need your team’s complete
dedication and focus. For this reason, make sure that you’re also competitive in regards to your PI’s expertise, your staff’s
training, your contacts with the real outside world, your reach to the community, your relations with your business partners,
etc. Real-life effort, expertise, and dedication are crucial if you wish to stand out from all the other research sites in this
industry. By showing your excellence a couple of times, sponsors and CROs will gain trust in you as a clinical research site,
word-of-mouth will spread, and as a result, you will establish your place as a good clinical research site in the industry.
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