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European Pharmaceutical Contractor

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Summer 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
Despite the difficult economic times, the market for toxicology and animal pharmacology CROs remains strong. Graham Hughes, EPC's Editor points out some emerging trends as the pharma industry moves forward.  
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During the past 10 years, the number of biopharmaceuticals in the market has exploded and we expect this trend to continue. Scott E Boley of MPI Research highlights the differences between biopharmaceuticals and their predecessor small molecules, with respect to nonclinical development.  
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When it comes to making decisions, are you overwhelmed by too many options? Choosing the right outsourcing partner is crucial and the selection process can be made simpler if you consider the key factors identified by David Tudbury and Vikki Renwick at Tepnel Pharma Services.  
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Marina Gornostai of Dila and Oleksii Mikheiev of Verum highlight the regulatory changes concerning clinical trials in Ukraine and the advantages of conducting trials in the region.  
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Sabine Hutchison, Susan Philippo and Ron van Eijsden of Docs Global discuss the effect of the wave of redundancies in the pharma and biotech industries, and consider how this challenging economic environment will cause organisations to approach staffing in a new and flexible way.  
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Legal & Regulatory
Globalisation of the pharmaceutical market means new drugs can have extensive patient exposure over a short period of time and thus proactive pharmacovigilance is imperative. Alison Bond and Katherine Hutchinson at Quanticate emphasise how integrating safety checks throughout the drug development process will help to achieve this aim.  
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Outsourcing regulatory affairs offers significant benefits, but it can also present real issues if not approached in the right way. Jonathan Trethowan of TRAC outlines some key questions to ask in order to ensure you reap only the benefits.  
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As Suzanne Rab and Robert F Leibenluft of Hogan Lovells look at some cases of the UK Office of Fair Trading versus pharma companies regarding competition and generic substitutes, one wonders if we really can determine when an ‘incremental improvement’ is important enough to avoid antitrust violation.  
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Clinical Development
A clinical trial cannot exist without the patients, thus their recruitment and retention are two critical targets to reduce trial timelines. Graham Wylie of the Medical Research Network provides a model with some effective tools and techniques.  
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The phrase 'time is money' certanily applies to pharmaceuticals; Graham Woods of Cetero Research illustrates how to safely accelerate through the drug development race track and shorten the journey from proof-of-concept to first-in-human studies.  
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When it comes to the safety of new medicines and vaccines, monitoring for adverse side effects should be carried out more actively post-market. Marco Hoekendijk and Arnold Chan at i3 Drug Safety highlight the importance of this approach citing the H1N1 vaccine as an example.  
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Data Management & IT Solutions
Do you know your EDC from your IVR/IWR, DDC, RFD and EHR, and have a grasp of their differences and benefits? Ross Rothmeier at Covance discusses electronic data and the need to adapt and integrate it with other systems, such as an electronic trial management system, to improve the efficiency of drug development.  
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EDC might be the norm for clinical studies today but software on its own will not increase efficiency; Debra Jendrasek and Greg Johnson at Chiltern describe the importance of good leadership for a successful study.  
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LABS & Logistics
Lori A Ball of Biostorage Technologies stresses the importance of logistics in the clinical research process and how the right logistical service partner and efficient cold chain management can result in cost and time savings.  
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The recent disruptions due to the Eyjafjallajökull volcano have highlighted how dependent we are on efficient transport systems. Eric Newman at ProTecht Risk Solutions identifies climatic conditions as one of the factors to consider when developing an effective cold chain management programme.  
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SPECIAL FEATURE: ONCOLOGY
Edwin Klumper of SMS-oncology delves into the ‘whats’ and ‘whys’ of personalised medicine for the treatment of cancers, and the advantages it could hold for patients and drug companies alike.  
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Standardised oncology assessment criteria are essential to the validity of oncology clinical trial outcome data, explain Stephen Bates and Kelie Luby at Perceptive Informatics.  
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