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PUBLICATIONS

European Pharmaceutical Contractor

epc
Spring 2010

European Pharmaceutical Contractor (EPC) is designed to fill a unique position in pharmaceutical publishing. Providing a dedicated platform of communication and information for the international pharmaceutical contract market, it consists of a series of articles and case studies written by eminent figures in contractor groups and traditional multinational pharmaceutical companies.

   
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Marketplace & Business
With the world's biggest population and one of its fastest growing pharmaceutical markets, the benefits of conducting clinical trials in China are overwhelming. Albert Liou at PAREXEL International explores the Chinese R&D landscape in more detail.
 
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Gail Kniveton at i3 Pharma Resourcing examines the critical but often overlooked area of staff training, arguing that in times of economic difficulty, it is more important than ever for companies to choose the right training strategy and exploit it to the full.  
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Management teams seeking improvements to their bottom line and operational performance are showing renewed interest in Lean and Six Sigma ways of thinking. Julian Mosquera at LCP Consulting takes a fresh look at the most effective means of adopting these methodologies.  
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Legal & Regulatory
Christopher Beckham and Bruce C Haas at Fitzpatrick, Cella, Harper & Scinto discuss why intellectual property procurement and enforcement have become greater priorities for the pharma industry in the context of the global economic downturn.  
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Clinical Development
Paper-based methods of collecting patient data are increasingly being cast aside in favour of electronic solutions. Mark Taggart and patrick Hughes at Exco InTouch look at how the mobile phone revolution can help to increase efficiency and reliability in the patient reporting process  
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Adrian Iancu at Global Clinical Trials reviews the impressive development of the clinical research landscape in Romania since its accession to the EU in 2007, looking at the country's advantages in terms of demographics and research experience.  
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Negotiating financial agreements between sponsors and CROs can be fraught with difficulty. Anna Ravdel at Synergy Research Grouo examines the change order process in detail, outlining the key choices to consider.  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
Lee Ann Applegate at the University Hospital of Lausanne (CHUV) and Dominique P Pioletti at the Swiss Federal Institute of Technology Lausanne (EPFL) advocate an interdisciplinary approach to developing new therapies, which can help to assure patient safety.  
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Although the practice of medicine has traditionally focused on population analyses, it is now widely acknowledged that techniques of personalised medicine can offer significant benefits to patients; David S Lester of ITHW reviews developments in the field.  
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Kathryn Chapman and Vicky Robinson at the National Centre for Replacement, Refinement and Reduction of Animals in Research present the need to change accepted testing methods in light of the growing redundancy of animal research in certain areas.  
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Data Management & IT Solutions
A bottle of wine has more in common with standards for clinical data than you might think, explain Dave Iberson-Hurst and AJ de Montjoie at CDISC, with insight into the past, present and future of CDISC standards.  
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Andrew MacGarvey at Quanticate discusses the shift away from 'treating sickness' and towards 'managing wellness' in the healthcare industry, and considers the role that the collection, cleaning and reporting of clinical data has to play in this progression.  
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LABS & Logistics
Amy Furlong at ERT returns to the theme of centralised ECG data collection, looking at the advantage of this paradigm when compared to the traditional decentralisd model, which include greater consistency and cost savings.  
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Everyone involved in the cold chain is aware of the need to keep things cool, but a recent report in the UK has highlighted the dangers of temperatures falling too low; Ana Carmona-Rodriguez at Gemini Data Loggers (UK) Ltd and Dawn Brown, freelance Consultant, show how data logging can help meet regulatory requirements.  
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Jean Bédard from Alternatives Technologie Pharma Inc discusses how automatic monitoring technology can make the business of avoiding temperature extremes in the pharmaceutical cool chain simpler and more transparent.  
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