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European Pharmaceutical Contractor

epc
Winter 2008
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EPC provides a unique platform of communication for the market across Europe, North America and the rest of the developed world. To find out what's hot in the world of pharmaceuticals, take a look below at the range of articles featured in the current issue of EPC.
   
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Marketplace & Business
Trends in the CRO market over 2008 come under the microscope of Graham Hughes, Editor of EPC and a Pharmaceutical Consultant  
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Julianne Hull at Wyeth believes that with commitment and mutual respect, business process outsourcing can lead to benefits that are well worth the effort and initial outlay  
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Korea is one of the fastest growing countries for clinical trials. Young Jack Lee at LSK Global Pharma Services points out that, although holding trials in Korea may not be low-cost, it is certainly cost effective  
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Legal & Regulatory
Paul Ranson at Fasken Martineau LLP sets out guidelines for negotiating and drafting contracts for outsourcing clinical research  
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Edgar H Adams, Robert Bader and Robin Carter at Covance Periapproval Services investigate the recent history of and developments in risk aversion and clinical development  
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Kristiina Liljedahl and Linda Berggren at Borenius & Kemppinen discuss major changes in the Finnish pharmaceutical reimbursement system  
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Clinical Development
Russell Neal and Annamaria Muroni at Clinical Network Services urge companies to take a leap from the world they know and explore the opportunities that Australia has to offer  
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Lani Hashimoto and Kim Boericke at i3 Research discuss methods of streamlining clinical trials in order to save time and costs by improving efficiency  
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There is a silver lining to the economic crisis: the downturns have pushed companies into improving efficiency and productivity. Liz Moench at MediciGlobal provides 10 strategies for saving time and cost for patient recruitment and retention  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
Helen Brooker and Nicole Meinel at Cognitive Drug Research explain that assessing the cognitive effects of drugs at an early stage in clinical trials can reduce the likelihood of a drug failing at a later stage of development; thereby saving time and money  
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Rob Zuiker and Zuzana Diamant at Centre for Human Drug Research (CHDR) discuss the added value of non-invasive biomarkers in early phase clinical trials of asthma  
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Alan Goldberg at the Johns Hopkins University Center for Alternatives to Animal Testing and Thomas Hartung of the EU Joint Research Centre and the University of Konstanz believe that, although toxicology is in crisis, there is a silver lining: the situation represents a driving force for change, and offers enormous opportunities  
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Data Management & IT Solutions
Sam Singh at ACM-Pivotal explores the evolution of laboratory information management systems (LIMS) from the point of view of a global clinical trials organisation  
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Jules Mitchel and Irene Ghilezan at Target Health Inc, Theresa Luna and Susan Carroll at Prometheus Laboratories, and Aida Bibliowicz at Cato Research Ltd, feel that turning away from our love of paper is the best way to optimise clinical trials  
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Dave Kloc at Netezza explains how the pharmaceutical industry can satisfy its need for data analysis by identifying and employing data warehouse appliances  
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Patrick Baudouin at SDL examines why global regulations have been the catalyst for higher translation standards across the life sciences industry  
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With eCTD now being recommended by regulatory agencies in Europe and the US, Keith Williams at Good Products Ltd examines the problems and advantages this can offer, and evaluates the new technologies that are developing as a result  
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Gunter Bellaire, Kevin Jaynes and Bill Byrom at Perceptive Informatics evaluate different medical imaging systems to improve productivity and efficiency of clinical trials utilising core medical imaging components and eClinical integration points  
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LABS & Logistics
Peter Kralinger at Carrymed Pharma & Transport discusses how temperatures can be best maintained during periods of transportation through an integrated approach  
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Nigel Cryer at Hamdrake Services considers how logistics can complete a pharmaceutical dream or turn it into a nightmare  
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ECG CORE LABS & CARDIAC SAFETY
Recent findings demonstrating serious safety issues with certain anti-diabetic drugs have led to increased guidelines and legislation. Didier Saur at ICON Clinical Research examines this and argues that reducing cardiovascular risk must always be the primary concern  
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Pascal Voiriot at CardiaBase examines a recent roundtable discussion on the guidelines surrounding cardiac safety and looks ahead to the future  
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