Ahead of the marcus evans Evolution Summit November 2019, read here an interview with Dunya Botetzayas discussing how risk-based monitoring can have a positive effect on a study site

1. Evolving Risk-Based Monitoring
to Improve Clinical Studies
Interview with: Dunya Botetzayas,
Senior Director Clinical Monitoring,
Veristat
“Risk-based monitoring is meant to
improve patient safety and data
integrity risks in clinical studies. When
sponsors and CROs leverage available
technologies and develop a risk-based
monitoring plan upfront, it can lead to
efficiencies for site personnel and
CRAs,” states Dunya Botetzayas, Senior
Director Clinical Monitoring & Site
Management, Veristat. “However, this
changes the role of CRAs in clinical
research.”
Veristat is a solution provider at the
marcus evans Evolution Summit
November 2019, taking place in
Boston, Massachusetts, November
18-20, 2019.
How is risk-based monitoring
impacting study sites?
Risk-based monitoring should have a
positive effect on a study site. When
sponsors and CROs leverage available
technologies and develop a risk-based
monitoring plan upfront, it leads to less
data collection for site personnel and
less on-site data monitoring by CRAs.
CRAs can focus on other activities, such
as the quality and performance of the
site, ensuring patients were enrolled
according to protocol criteria, evaluating
consents, reviewing drug accountability,
and ensuring adverse events are
identified and reported promptly. With
centralized monitoring increasing and
on-site monitoring becoming less
frequent, sites are reporting some
frustrations. Clinical trials without
efficient data collection technologies will
continue to rely on the sites to scan
pages and pages of documents so that
CRAs can monitor remotely. This is not
the intent of risk-based monitoring. For
risk-based monitoring to work for sites,
the trial must be designed to collect and
analyze the data more reflectively and
efficiently.
How is the role of the CRA chang-
ing? How do you envision the role in
five to ten years from now?
The role of the CRA is evolving. CRAs
currently focus on reviewing the source
data rather than looking at critical study
risks, and identifying ethics and safety
measures. In risk-based monitoring, the
CRA’s ability to evaluate the overall
performance of the site really comes
into play. Instead of focusing on
documents that do not have a signifi-
cant impact on the trial, such as an
outdated lab license, they should be
looking at adverse events and consent.
Many CROs, like Veristat, have created
a new Site Manager role to take over
these administrative functions of CRAs.
This allows CRAs to focus on critical
outcomes and not just project scope.
Additionally, Site Managers become the
day-to-day support system for the sites,
while CRAs are traveling or implement-
ing risk mitigation measures.
Over the next few years, CRAs will need
to think and perform more like auditors
and relationship managers. CRAs will
always play a critical role in clinical
trials, but they will acquire an increasing
focus on identifying and mitigating risks.
What training is required of CRAs to
ensure clinical trial quality?
Years ago, CRAs were medically trained
personnel, such as physicians and
nurses, with in-depth knowledge of the
diseases being studied. The industry
and hiring practices of CRAs has
changed. There is a shortage of
physicians and nurses with in-depth
expertise in every disease or novel
therapeutic modality being studied
today. Therefore, sponsors and CROs
today must pair medical experts
knowledgeable in the study’s disease
state to mentor and train the CRAs.
These medical experts ensure that the
CRA understands the protocol, the data
being collected, the compound’s
mechanism of action, possible side
effects, and pathology outcome ranges.
CRAs need to have a strong understand-
ing of the disease itself or else they will
not know if the data they are reviewing
makes sense or is accurate.
How does the industry need to
change to incorporate risk-based
monitoring approaches success-
fully?
Timelines are becoming more aggres-
sive, budgets tighter, headcounts
smaller yet the demand for running
safer, more complex, and faster trials is
increasing. A risk-based monitoring
approach can shorten overall timelines
and reinforce the FDA’s goal of
improving patient safety and mitigating
data integrity risks. However, to
accomplish this, sponsors and CROs
must leverage available technologies
and develop a risk-based monitoring
plan upfront. This requires more up-
front planning – which increases study
start-up time and cost.
A shift in mindset by sponsors, CROs,
and sites is required to embrace risk-
based approaches. It is true that risk-
mitigation planning takes longer and
costs more at the beginning. However,
the efficiencies realized down the line
with less monitoring time and costs, and
the assurance of improved patient
safety and clinical data integrity, make
this evolution worthwhile.
There is a need
for CRAs to be
more focused on
critical outcomes
rather than the
entire scope

2. The Pharma Network – marcus
evans Summits group delivers
peer-to-peer information on
strategic matters, professional
t r e n d s a n d b r e a k t h r o u g h
innovations.
Please note that the Summit is a
closed business event and the
number of participants strictly
limited.
About the Evolution Summit November 2019
The 20th Evolution Summit is the premium forum bringing clinical trial experts from
leading drug development companies and solution providers together. The Summit
offers an intimate environment for a focused discussion of key new drivers shaping
drug development. Taking place at Fairmont Copley Plaza, Boston, Massachusetts,
November 18-20, 2019, the Summit includes presentations on the artificial
intelligence era, surpassing recruitment, retention and patient engagement goals,
incorporating innovation in clinical trials, and developing a patient-centric approach.
www.evolutionsummit.com
Contact
Sarin Kouyoumdjian-Gurunlian, Press Manager, marcus evans, Summits Division
Tel: + 357 22 849 313
Email: press@marcusevanscy.com
For more information please send an email to press@marcusevanscy.com
All rights reserved. The above content may be republished or reproduced. Kindly
inform us by sending an email to press@marcusevanscy.com
About Veristat
Veristat is a scientifically-oriented and impactful full-service CRO that is committed to partnering with pharmaceutical,
biotechnology, and medical device firms to advance their therapies throughout the entire clinical development and regulatory
submission process. Our team provides experience-based strategic decision-making, the operational efficiencies to manage and
monitor international trials, the biometrics expertise to collect, analyze and report clinical trial data to various regulatory agencies,
and the therapeutic and medical proficiency to oversee the entire process.
www.veristat.com
About marcus evans Summits
marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss
strategies and solutions. Held at exclusive locations around the world, these events provide attendees with a unique opportunity to
individually tailor their schedules of keynote presentations, case studies, roundtables and one-on-one business meetings.
For more information, please visit: www.marcusevans.com
Upcoming Events
Evolution Summit (Europe) - www.evolution-summit.com
To view the web version of this interview, please click here:
http://events.marcusevans-events.com/evolution2019-dunya-botetzayas