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European Pharmaceutical Contractor

epc
Winter 2001
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 this issue of EPC
   
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introduction
In his Editor's Letter, Dr Graham Hughes summarises the articles in this 'new-look' issue of EPC  
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Marketplace & Business
When choosing a CRO, there should be a balanced assessment of all potential factors. Andy Broadhurst, Research Director at Heart Research, UK, discusses Outsourcing Your Clinical Trial - The Search for Added Value  
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Dr David Cavalla, CEO of Arachnova Ltd considers the benefits of the virtual company (increased flexibility and reduced exposure to infrastructure costs) in Outsourcing R&D - The Value of Virtuality  
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Clinical Trials
In Automating the Preparation of Test Articles and Clinical Trial Supplies, Imogen Gill, David Edwards, Bruce Macmichael, and Ian Smith of Meridica Limited, UK, explain how automation of preclinical and clinical trial supplies can provide a step towards increasing speed to market  
For anyone working in clinical trials, Yugoslavia is not the first place that springs to mind. However, Helen Springford, Director of European Business Development, and Pavle Vukojevic, Clinical Research Associate for Pharm-Olam International, highlight the country's potential in Yugoslavia - A Re-Emerging Market for Clinical Trials  
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Legal & Regulatory
Whilst the Internet offers opportunities to develop brands, it also harbours many dangers for pharmaceutical companies. Clarke Graham, Partner at Marks & Clerk, London, investigates the effect of the Internet on intellectual property in A Shot in the Arm for the Pharmaceutical Industry - Protecting Pharmaceutical Brands and the Impact of the Internet  
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Drug Discovery, Development & Delivery
In The Trojan Horse of Oncology - The Role of Stealth Drug Delivery, Dr Peter Cheverton MBChB, MMed Rad(T), Director of Oncology for Daiichi Pharmaceuticals UK Ltd, looks at the latest methods available to oncologists in the fight against cancer  
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Dr Linda Potgieter, Senior Director at FARMOVS-PAREXEL, South Africa, assesses possible solutions and suggestions to promote the harmonisation of bioequivalence and bioavailability issues across all global CROs, in Practical Issues Regarding Bioequivalence Studies  
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The optimisation of ovarian carcinoma therapy is outlined in conversation with Dr Uwe Wagner, Deputy Medical Director and Lecturer at the University of Tьbingen's Gynaecological Hospital, in The Monoclonal Anti-Idiotype Antibody ACA 125 - A Breakthrough for Ovarian Cancer  
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Dr Graham Hughes, Editor of EPC, discusses the aims of the New Safe Medicines Faster initiative, launched by the European Federation of Pharmaceutical Sciences in 2000  
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Patient Recruitment
Jane Baguley, Director of Business Management Services for Quintiles Europe reviews the options available to maximise the chance of achieving patient recruitment objectives, in The Challenge of Patient Recruitment  
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COUNTRY FOCUS - JAPAN
In A Competitive Analysis of the Japanese Pharmaceutical and Biotechnology Industries, Anil Vaidya, Export Promoter - Japan Unit, Trade Partners UK, explains how despite the fact that Japan is the second largest pharmaceutical market in the world, Japanese pharmaceutical companies are concerned about their future prospects  
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Given that SMOs are a fairly new phenomenon even in the West, Japanese sponsors could be excused for not acknowledging the contribution that these organisations can make to clinical plans. Tristan Brittain-Dissont, Commercial Director at Intercern Clinical Research Networks, discusses SMOs - Creating a New Outsourcing Strategy for Japanese Pharmaceutical Companies  
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SPECIAL FEATURE: CENTRAL LABORATORIES
In Using Polymer Beads to Assist Solution Phase Synthesis, Andrew Coffey PhD, Solid Phase Synthesis Support Product Manager at Polymer Laboratories Ltd, considers the real advantages to be gained in utilising compounds tethered to polymer beads  
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EPC's Editor, Dr Graham Hughes, reviews the latest DIA meeting which was held at the Royal Park at Evian-les Bains, in An Analysis of the Future - The Bloodless Coup  
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LABS & Logistics
Dr Drew Kilpatrick, Associate Director of Project Management at Inveresk Research and Peter Crespin of 'The Writers Bureau', highlight the benefits of using courier integration systems for the more efficient management of logistic information, in Improving Clinical Trial Management - Moving Shipping Logistics Online  
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DATA MANAGEMENT
Technological advances in IVRS have led to the efficient management of multiple facets of clinical trial research. James S. Primerano Jr, Business Development Manager with Interactive Clinical Technologies (ICTI), puts forward Integrative Protocol Design Considerations Employing Interactive Voice Response System (IVRS) Technology  
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Jeffrey Klofft, Vice President/General Manager of Data Management Products, and Paul Bleicher, Chairman and Chief Science Officer at Phase Forward Incorporated, investigate the next stage in the evolution of the clinical trial infrastructure in e-CDM - The Complete Solution for Clinical Data Management  
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In clinical trials, paper-based systems can lead to time delays and quality problems. Maryann Lombardo, an Analyst at Datamonitor, recommends the electronic alternative in Electronic Data Capture - Achieving the Promise of More Efficient Trials  
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The construction of an EDC library is of primary importance to achieving a successful project. Linda Mook and Frank Zweerus, Directors of Product Management at Araccel, explain why in The Value of e-Libraries in EDC Scale-Up Scenarios  
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In Electronic Data Capture - Paving the Way for Successful Clinical Trials, Wolfgang J. Oestreich, Managing Director of Dr Oestreich + Partners, outlines the advantages of EDC over the more traditional paper-based systems  
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Douglas Bain, Director of TEAMworks, UK, explains how e-CDM - The Next Generation of Clinical Research Information Management Systems, can add value to the clinical trials process  
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