Interview with: Tomasz Anyszek, Director, Synevo Central Lab, a sponsor company at the marcus evans Evolution Summit 2013, suggests a cost-effective way of getting clinical data harmonised.
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Interview with: Tomasz Anyszek, Director, Synevo Central Lab
1. Interview with: Tomasz Anyszek,
Director, Synevo Central Lab
“For clinical trial data interpretation
and statistical evaluation, having a
harmonised set of data is a must.
However, what many companies do
today is spend half their budget on
shipping samples to a central lab, when
a more cost-effective option is
available,” according to Tomasz
Anyszek, Director, Synevo Central
Lab.
From a sponsor company at the marcus
evans Evolution Summit 2013,
taking place in Monte Carlo, Monaco,
21 - 23 October, Anyszek gives an
overview of what is challenging Chief
Medical Officers (CMOs) of clinical
trials and discusses the benefits of
working with a network of local labs that
use the same processes and
procedures.
How could CMOs enhance the
quality of their clinical trial data?
One of their biggest problems today is
the harmonisation of data. Some
companies use one central location to
get results that are harmonised as they
come from one lab. There are technical
problems with this option, such as the
high cost of shipping samples, problems
crossing borders and permit or customs
issues, which all result in a long
turnaround time. Other companies use
local labs that are close to the
investigators, so everything is done
quicker, but there is the big problem of
having data from different labs. Must
studies run on a central lab model
because data harmonisation is
challenging. For safety reasons,
centralisation is a must for some
studies.
From our point of view, there is a third
option, where trials utilise the services
of labs located close to the
investigators, but the procedures are
fully harmonised between them. At the
end of the project, they get a
harmonised set of data that is almost
the same as the set of data they would
get by using one lab. This is the model
we are able to offer.
How does Synevo ensure data are
harmonised?
First, we have the same equipment in
our labs and use the same testing
methods, so results are comparable by
definition. We are able to define one set
of reference ranges, which is important
for the interpretation of the results.
We have the same quality control
processes for the identical part of the
work, in order to show comparability.
Additionally, the procedures for kits
production, and sample registration,
resolution, rejection and shipment are
the same. There are no differences
between countries and investigators. We
have at least one lab in each country we
operate in that is harmonised with each
other.
What issues and costs does this
avoid?
If everything is within the European
Union, it is not a big problem. You can
send samples without permits and
everything is well regulated. But for
countries like Russia, Ukraine, Georgia,
Turkey, Serbia, Moldova, you need
applications and permits from the
Ministries of Health. You have to pay a
lot of money and wait to see what the
customs officers will do. It is easier and
cheaper to do it internally, as it is
cheaper to ship nationally than
internationally.
Paying for shipment is a clear waste of
money, because there is no quality or
data in the service. I see studies where
half of the budget went on shipment
costs. This is clearly not how it should
be. One of the simplest ways to reduce
the study budget is to reduce the
investment of the sponsor on shipping.
It will not impact the quality of the data
in any way. Big pharmaceutical
companies may have the money to
spend on this, but small biotechs need
to count each euro. They should
seriously reconsider whether the central
lab model is the best choice for their
project.
One of the
simplest
ways to
reduce the
study budget
is to
reduce the
investment
of the
sponsor on
shipping
Achieving Clinical Trial Data Harmonisation
in Multinational Projects
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About the Evolution Summit 2013
This unique forum will take place at Le Méridien Beach Plaza, Monte-Carlo, Monaco,
21 - 23 October 2013. Offering much more than any conference, seminar or trade
show, this exclusive meeting will bring together esteemed industry thought leaders
and solution providers to a highly focused and interactive networking event. The
Summit includes presentations on progressing clinical programmes, site selection,
competing in the new drug development paradigm and winning market access.
www.evolution-summit.com
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About Synevo Central Lab
Synevo Central Labs is the largest wholly-owned and fully-harmonized network of central laboratories in Europe dedicated
exclusively to support clinical trials. Having an extensive menu of 1,500 validated assays, routine and advanced diagnostics, we are
unquestionable leader in the region. We offer a comprehensive central laboratory services, starting from kits production through
sample logistics and testing to results reporting with 21CFRPart11 proprietary software.
www.synevo-centrallabs.eu
About marcus evans Summits
marcus evans Summits are high level business forums for the world’s leading decision-makers to meet, learn and discuss
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individually tailor their schedules of keynote presentations, case studies, roundtables and one-to-one business meetings.
For more information, please visit: www.marcusevans.com
Upcoming Events
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To view the web version of this interview, please click here: www.evolution-summit.com/TomaszAnyszek