Pharmaceutical Executive Europe - March 2007 - (Page 19)
Advances from Europe Ian Jennings reviews the changes and advancements in
the European pharmaceutical sector and looks at how they are impacting on
clinical technology. he global pharmaceutical industry is continuing to
experience multiple pressures — consolidation, increased regulatory
demands and compressed drug pipelines, to name but a few. European
operations also have to contend with potential language barriers and
diversity in the way the clinical trial process is administered, as each
countr y is subject not only to the European Medicines Agency EMEA but
also to its own regulator y body. Notwithstanding, or perhaps due to,
these additional challenges, clinical technology is becoming more widely
accepted and adoption of new technologies in Europe is growing. This is
particularly true of electronic patient reported outcomes ePRO ,
interactive voice response systems IVRS and electronic data capture EDC .
According to CenterWatch,1 biopharma companies and CROs are already
employing EDC in 44% and 39% of trials respectively. Given Forrester
Research’s2 estimate of operational savings from the use of EDC in Phase
II trials alone amounting to around $350,000 per trial rising to $6.3
million in Phase III , the future of EDC looks assured. T Winds of change
Essentially, the theme underlying the market at the moment is one of
change. So, what are the factors influencing change? The technology market
place remains unchanged in that it continues to focus on international
trials run by large pharma companies. However, where global decisions
relating to technology may historically have been driven from corporate
headquarters elsewhere, there is an increase in these decisions being led
from within Europe. Consequently, many North American technology companies
are investing in European facilities and representation in Europe. European
expansion The expansion of the EU has had an interesting impact on the
pharma industry. Most people associate the term ‘emerging markets’
with countries such as China and India, but the Eastern European countries
that have recently been absorbed into the EU also represent a significant
opportunity. Furthermore, they provide a large, untapped resource for drug
development in the form of a huge population of 19 www.pharmexeceurope.com
http://www.pharmexeceurope.com
Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - March 2007
Content
Linking People, Process and Technology
Building Alliances
Finding Success in Asia
Selecting South Africa
Advance from Europe
EDC: Are We Missing the Boat?
The Right Equipment
Next Stop: Vienna
Pharmaceutical Executive Europe - March 2007
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