Matt Kepple of Primorus Clinical Trials Ltd, a solution provider at the marcus evans Evolution Summit 2013, on finding the balance between clinical trial standardization and localization. Interview with: Matt Kepple, Managing Director, Primorus Clinical Trials Ltd

1. Standardization Vs Localization -
How Chief Medical Officers Can Find the Balance
This is similar to innovation within the
pharmaceutical industry, where if you
have too much centralization in
producing new products, you stifle
innovation and creativity.
In large companies where there is a
large amount of centralization and
standard operating procedures, it leads
to inefficiencies at lower levels within
particular countries. So centralization is
not great for decision-making.
Interview with: M a t t
Managing Director,
Clinical Trials Ltd
Kepple,
Primorus
What could they do?
To improve services there needs to be a
To improve
“In highly regulated industries such as
balance between centralization and
localization. Self-managed teams and
more localized standards of operating
services
drug development, standardization is
essential for managing the more
replicable parts of process, while local
procedures would make them more
efficient. Knowledge transfer plays a key
part here.
there needs
knowledge and agility are critical for the
aspects that are more variable,” said
Matt Kepple, Managing Director,
We are seeing many contract research
organizations (CROs) in the market
to be
Primorus Clinical Trials Ltd .
However, finding this balance when
conducting clinical trials is often a
forming into smaller CROs with
geographical expertise or larger CROs
with international coverage. There are
a balance
challenge, he added.
Primorus Clinical Trials Ltd is an e-
many mergers and acquisitions going
on. between
clinical company attending the marcus
evans Evolution Summit 2013, in
Palm Beach, Florida, May 8-10.
How could CMOs make better use of
e-learning tools? centralization
Why is standardization a challenge
for Chief Medical Officers (CMOs)?
E-learning is useful when a lot of staff
training has to be completed on
repetitive work or if they need to make
and
One of the difficulties is handling
standardization in different regions,
sure certain work processes are
maintained from year to year. localization
when some aspects of clinical trials are Staff can go through large amounts of
intrinsically uncontrollable. Services training in this way, however, e-learning
such as recruitment and quality of should be in conjunction with hands-on
conduct are uncontrollable, so every training, particularly with core
time they are performed, a different leadership groups, to aid knowledge
result is achieved. Therefore, they are transfer.
not easily standardized. To handle these
aspects, they require either experienced Electronic training is very important, but
personnel or adaptable procedures. it should be combined with other
Agility is quite important here. methods for best results.

2. The Pharma Network – marcus About the Evolution Summit 2013
evans Summits group delivers
peer-to-peer information on This unique forum will take place at The Ritz-Carlton, Palm Beach, Florida, May
strategic matters, professional 8-10, 2013. Offering much more than any conference, exhibition or trade show, this
trends and breakthrough exclusive meeting will bring together esteemed industry thought leaders and
innovations. solution providers to a highly focused and interactive networking event. The
Summit includes presentations on improving trial performance, establishing
strategic alliances, site selection and e-recruitment.
www.evolutionsummit.com
Please note that the Summit is a
closed business event and the
Contact
number of participants strictly
limited. 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 Primorus Clinical Trials Ltd
Primorus is a full service CRO, providing early phase monitoring, regulatory, data management, biostatistics and QA services, with
an accredited phase I clinical trials facility. Primorus conducts research for Pharma, Biotech and Medical device clients in
Australasia.
www.primorus.co.nz
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, think tanks, seminars and one-on-one business meetings.
For more information, please visit: www.marcusevans.com
Upcoming Events
Discovery Summit (Europe) - www.discovery-summit.com
Evolution Summit (Europe) - www.evolution-summit.com
To view the web version of this interview, please click here: www.evolutionsummit.com/MattKepple