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

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - March 2007

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