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European Pharmaceutical Contractor

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Autumn 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
Following the recent publication of the long-awaited European Commission Final Report on its enquiry into the pharmaceutical sector, Catriona Hatton, Suzanne Rab, Jean-Michel Coumes and David Cardwell at Hogan and Hartson outline its key findings and implications for the industry.  
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Claudio A Lorck and Arnim Laicher at Temmler Weker GmbH investigate how current economic conditions in the pharmaceutical industry are affecting the outsourcing market, and review the most effective tactical and strategic approaches to outsourcing wisely.  
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Legal & Regulatory
Helen Brooker at Cognitive Drug Research (CDR) Ltd considers how clinical studies working in neurodegenerative diseases can be improved in the light of new EMEA guidelines for companies developing medicines for the treatment of Alzheimer's disease, other dementias and Parkinson's disease.  
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Alejandro Arana and Félix Arellano of Risk MR Pharmacovigilance Services and Teresa Cuchí Actiomed look at the progression of pharmacovigilance in the EU, and assess the likely impact of recent proposals for new Europe-wide legislation.  
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Clinical Development
Changes in the global economy over the last decade have had a dramatic impact on biotech and pharma companies, but central laboratories can play a key role in mitigating the impact of financial pressure, says Hermann Schulz at INTERLAB central lab services - worldwide GmbH.  
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Oleg Tikhonov, Natalia Ukolova and Platon Komissarov at Synergy Research Group discuss the advantages of regional sites - as opposed to the major cities of Moscow and St Petersburg - when recruiting patients for clinical trials in Russia, and offer some invaluable advice.  
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The data monitoring committee (DMC) has an important role to play in upholding ethical standards and ensuring that the objectives of a clinical trial are reasonable; however its role is not always fully valued. Ronald Kershner at AAIPharma, Inc suggests ways in which the function of a DMC can be optimised.  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
The reduction of animal testing is not just a matter of ethical concern but also of better scientific practice. Nirmala Bhogal, Rita Seabra and Michelle Hudson at FRAME explore methodological approaches which can limit the use of animals in clinical research.  
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Continuing the theme of reducing animal testing, Peter Ertl and Lukas Richter at the Austrian Institute of Technology ask why so many drugs fail despite initial successful animal testing, and examine the alternative of developing 3D cell culture on chip.

 
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David Ward at Melbourn Scientific explains why close integration between formulation, analysis and manufacture can help to identify potential problems as early as possible in the development process, reducing the likelihood of costly and time-consuming failures.  
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CDISC & Electronic Data Capture
Joris De Bondt at SGS Life Sciences discusses the benefits of Clinical Data Acquisition Standards Harmonization (CDASH) - one particular standard in the CDISC portfolio whose benefits are already being felt in EDC trials.  
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The integration of clinical research with healthcare has recently been a hot topic in the world of EDC. Jozef Aerts at XML4Pharma reviews the current situation, the regulatory issues, and hurdles for real-life implementation.  
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Mats Sundgren at AstraZeneca, Petra Wilson at Cisco, and independent consultant Isabelle de Zegher discuss the importance of electronic health records, explaining why failing to adopt their systematic use could have serious consequences for the EU.  
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The adoption of technology to enable CDISC standards paves the way to considerable benefits for CROs. Despite this, some organisations have been notably slow to react. Dave Smith at SAS UK considers the reasons why.  
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Barbara Rapchak at Leap of Faith Technologies, Inc describes how the latest telemonitoring technology can make a huge difference to quality of life for cancer patients, and support clinical research by improving compliance.  
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LABS & Logistics
Ken Lukes at Inmark argues that the increasingly multinational landscape in which businesses now operate has made harmonisation of temperature-controlled packaging systems more important than ever, and offers advice in achieving this objective.  
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The worldwide nature of clinical trials poses a considerable challenge to biotech and pharmaceutical companies, who are obliged to transport a wide variety of temperature-sensitive materials over vast distance and variable climatic conditions. Jeff Clark of BioStorage Technologies lays out the ground rules for effective cold chain logistics.  
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ECG CORE LABS & CARDIAC SAFETY
J Rick Turner of Quintiles ECG Services looks at the central importance of the ICH E14 thorough QT/QTc study in drug safety and evaluation, and gives insight into its design, methodology and interpretation.  
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