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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
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 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
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 info@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 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
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-to-one business meetings.
For more information, please visit: www.marcusevans.com
Upcoming Events
Discovery Summit (Europe) - www.discovery-summit.com
Evolution Summit (North America) - www.evolutionsummit.com
To view the web version of this interview, please click here: www.evolution-summit.com/TomaszAnyszek

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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
  • 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 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 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 info@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 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 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-to-one business meetings. For more information, please visit: www.marcusevans.com Upcoming Events Discovery Summit (Europe) - www.discovery-summit.com Evolution Summit (North America) - www.evolutionsummit.com To view the web version of this interview, please click here: www.evolution-summit.com/TomaszAnyszek