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European Pharmaceutical Contractor

epc
Winter 2009

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
At the end of what has been a gloomy year in economic terms, Graham Hughes reflects on how the industry has reacted to the financial crisis, reviewing in full the developments of 2009.  
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Silvia Esteban at GE Healthcare examines the role that asset management programmes can play in helping pharmaceutical and biotech companies face the demands of the current climate by unlocking hidden capital and driving efficiently  
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Derek Nelson at IBM ILOG discusses the need for pharmaceutical companies to consider carefully the effects of international tex regulations on their supply chain, and identifies the key challenges in achieving tax efficiency.  
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Legal & Regulatory
As the propsect of competition with cheap generic medicine looms on the horizon for many drug makers, Haydn Evans at CPA Global suggests steps that companies can take to guard intellectual property rights for as long as possible.  
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Clinical Development

Luca Cantini and Simona Colazzo at Crom present the background behind the recent expansion of clinical trials in central and eastern Europe, focusing in particular on the advantages of the region in terms of data quality.

 
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The rapid development of clinical trials facilities in post-Soviet nations means that cost-efficiency is no longer the overriding incentive to do business there; Lidia Gomenyuk and Marina Gornostai at Dila take Ukraine as a case study.  
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Lekishia White at Multipharma argues that a robust and reliable delivery network for the distribution of comparators and their ancillary supplies is a crucial element in ensuring that a clinical trial runs smoothly.  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
Societal acceptance of animal testing continues to increase dramatically; Bob Diderich and Laurence Musset from the Organisation for Economic Co-operation and Development look at initiatives to improve the regulatory acceptance of alternatives.  
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Brain positron emission tomography has the potential to facilitate much-needed research into Alzheimer's disease by acting as a biomarker, as Karl Herholz at the University of Manchester explains.  
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Data Management & IT Solutions
Joerg Dillert at Phase Forward discusses the advantages of the BRIDG and HL7 models in data collection, giving us an overview of their background, where they are today, and what we can expect in the future.  
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Study designs have a critical effect on the cost, time and complexity of handling information in a clinical trial. David Gemzik at Medidata Solutions, Inc explains how the harmonisation of these upstream designs and planning activities can yield results throughout the process.  
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SAS software can save time and resources if put to use at key stages in the standardised data handling and reporting process. Scott McGregor at S-cubed explains how the different functinos of the program can maximise the benefits of CDISC.  
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Making disparate information systems work together in such a way that communicated information retains its significance is no straightforward task, but the benefits to pharmacovigilance are considerable, as Julie James at Blue Wave Informatics points out.  
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LABS & Logistics
Geraint Thomas at Laminar Medica considers the social and regulatory obligations on the temperature-controlled packaging industry to cut waste, and looks at the different means by which this can be acheived.  
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New ECG solutions that integrate into existing frameworks can help clinical trials sponsors to benefit from a more efficient and cost-effective system; Amy Furlong at ERT assesses the advantages of centralised ECG data collection and analysis.  
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Studies to determine the effect of a new drug on cardiac repolarisation are now considered fundamental to the development process. Asif Naseem, Keith Berelowitz and Jörg Täubel at Richmond Pharmacology discuss methods of optimising QT/QTc studies.  
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