CWWeekly presents this feature as a way to
put the spotlight on issues faced by executives
in the clinical trials space. Ashok Ghone, Ph.D.,
is vice president of global services at Makro-
Care USA in New Jersey.
QCan you briefly explain the reasons
why centralized monitoring is becom-
ing an attractive alternative approach to
traditional clinical trial moni-
toring, given that only a few
sponsors have implemented
it while others are waiting to
gain more confidence in the
process?
ATraditional ways of
conducting frequent
monitoring visits are every
four to eight weeks at in-
vestigational sites and 100%
source data verification. However, they do
not necessarily result in higher data quality,
better monitoring of patient safety, or in
an understanding of the critical issues early
on in the process. So, there was a need to
look into alternative, intelligent and smarter
ways to achieve improved data quality and
patient safety in a cost-effective manner.
The centralized monitoring appears to be
the most suitable approach available today.
This newer approach can provide many of
the capabilities of on-site monitoring, as
well as additional capabilities. With the use
of technology like electronic data capture
and analytics tools, it is easy to look at the
data centrally or remotely to identify risk/
issues in real time basis and take proactive
or timely actions.
There are a couple of reasons why the
industry is slowly adopting this approach.
Centralized monitoring is a new ap-
proach to clinical trial management. It needs
change management in terms of process
restructuring, people alignment, training
and technology requirement. Therefore,
the adoption is slow, as sometimes people
are fearful of change management. It also
requires internal process change, new SOPs/
documentation development, getting the
right technology in place and, at the same
time, looking into developing new roles like
central monitors. As this is a very regulated
industry, it takes time to adopt any new
change. Take EDC, for example. The industry
has taken a good amount of time to convert
from paper to electronic data capture and
still we see some trials are being conducted
using paper.
Another reason may be that people are
worried about their jobs. Monitors/CRAs
feel that there will be less monitoring for
them, or some of them will not have work.
However, we need to understand that while
on-site monitoring visits will be reduced
and monitors will have less on-site work,
it opens new avenues for CRAs to get into
new roles of central monitors with proper
training. Now the industry will need these
new roles.
The key benefits of centralized monitor-
ing are how it helps improve data quality
with better efficiencies. Most big companies
have started implementing
this approach into practice.
Some of them are still run-
ning pilots to thoroughly gain
more confidence in the process
before fully implementing it
into practice and across their
studies. Running pilots takes
time.
QWhile the FDA encour-
ages sponsors to consider
changing their approach to monitoring, why
are some large companies hesitant to imple-
ment centralized monitoring?
AIt depends on the culture of organiza-
tions’ willingness to take risks and to
go for change management to reap the
benefits.
Centralized monitoring requires a positive
internal culture and senior management in-
volvement to drive change management to
implement the newer approach. So it really
varies from company to company.
But a good number of large compa-
nies are running the pilots and some have
already adopted centralized monitoring
into practice as a part of their risk-based
A CenterWatch Publication
Special Article Reprint • October 28, 2015
CWWeekly (ISSN 1528-5731). Volume 19, Issue 38. © 2015 CenterWatch centerwatch.com
Three Questions
Ashok Ghone, MakroCare USA
“[Centralizedmonitoring]canprovide
manyofthecapabilitiesofon-site
monitoring,aswellasadditional
capabilities.”
Ashok Ghone, vice president of
global services, MakroCare USA

monitoring. As clinical trials are getting
expensive, they want to validate the process
completely, get full confidence, before they
implement it to all studies in the practice.
Some companies are working with their CRO
partner or specialized service provider to
implement it.
QGiven that on-site monitoring accounts
for one-third of the overall costs of clini-
cal trial management, how does centralized
monitoring minimize on-site visits by identi-
fying risk/issues that improve the effective-
ness of CRAs and save sponsors’ money?
AMany aspects of onsite monitoring
can be accomplished by centralized
monitoring and it offers a proactive ap-
proach to identify risks/issues early on and
thereby helps in planning and triggering site
contact/visit based on the observed critical
risks/issues. With this approach, we do not
have to carry out routine monitoring visits
every four to eight weeks to sites.
Based on site performances, one can
optimize on-site monitoring visits and the
time that monitors spend at the site. As
monitors know the status of their sites, in
terms of issues and risks through centralized
monitoring, they can be more focused dur-
ing on-site monitoring and use their time
effectively.
As for direct savings, it comes from the
reduction in the number of monitored site
visits, reduction in monitors’time at the site
and travel costs. These changes will translate
into significant savings—especially if the
sponsor is working on a study with many
sites and long duration.
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