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International Clinical Trials

ict
Winter 2010
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. ICT 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 ICT.
   
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Regulatory & Business Practice
Five years after the implementation into national law of the Clinical Trials Directive, Elisabethann Wright and Wim Nauwelaerts at Hogan & Hartson LLP consider improvements to legislation in the EU that would make the region more attractive as a forum for conducting clinical trials.  
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Pandemic preparedness is a complex, but essential, requirement when attempting to ensure that clinical data is delivered to the sponsor on-time and on-budget, every time, asserts Jeffrey A Kueffer at INC Research.  
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Helena Korjonen of the National Heart Forum provides an insight into the current guidelines and regulations of trial registration for those working in clinical research - but explains that more studies are needed in order to improve clinical trial reporting.  
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Trial Management & Outsourcing
Mergers and acquisitions are on the rise, but for many they are not the only solution to either the innovation gap or the productivity equation; Dominique Demolle and Denis Gossen of Aepodia pinpoint the importance of fundamental business model transformation.  
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Berwyn Clarke of Lab21 Limited reviews the genetic parameters that are being introduced into personalised medicine, and explains why the pharmaceutical and diagnostics industries need to work together closely to ensure that the correct diagnostic tests are available to support the new use of these drugs as they are licensed.  
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Obtaining a robust pharmacokinetic/pharmacodynamic data set should be a priority in early-phase research; Geoffrey Banks at ClinPharm Consulting looks at ways to maximise the potential of industry sponsored clinical pharmacology studies.  
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The drug industry can increase the efficiency of multinational studies through a combination of more proactive management, alongside technologies and processes that provide organisations with a continuous flow of timely information, explains Michael Rosenberg or Health Decisions.  
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Anna Ravdel and Svetlana Timofeeva at Synergy Research Group outline the importance of a feasibility assessment for clinical trial planning - making sure that clinical, regulatory and logistics checks are all included in the process.  
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Faced with blockbuster patent expirations, Brendan Ellis at InCROM Europe charts the growing trend for pharma companies to collaborate on projects and also identified the pitfalls to avoid when setting up a patient PK study.  
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Regional trials
As clinical trials become increasingly global, Michael Smyth at TransPerfect looks at ways for biopharmaceutical companies and CROs to remain competitive - with the need for rapid adoption of electronic solutions at the top of the list.  
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In assessing China's attitude towards eClinical technologies, Bruce D Schatzman of StudyManager, Inc explains that it will be smaller EDC vendors that lead the revolution, offering capable systems at a price that small-to-medium size CROs and biopharma companies can afford.  
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With 58 per cent of clinical trials now using EDC, eClinical solutions appear to have reached a level of general acceptance. Gregg Dearhammer of i3 Statprobe considers what the future might look like as technology evolves to make the world of clinical trials more efficient.  
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With principal investigators tapping into the knowledge base of the wider research community, Amar PS Chahal of Velos, Inc highlights a growing trend towards data sharing and international participation.  
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THERAPEUTICS
Joe Keenan at Argutus Medical Ltd, on behalf of the SAFE-T consortium, reviews changes in drug discovery practices and the development of specific and sensitive safety biomarkers, predictive models, 'omics' approaches, translational methods and studies expected to reduce drug development failures.  
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With estimates from the World Health Organization that the diabetic population in developed countries is likely to reach 366 million in 2030, the diabetes market is an area of the pharmaceutical industry which demonstrates incredible growth opportunities, outlines Sylvia Miriyam Findlay at Frost and Sullivan.  
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Ethics & Risk Management
Nirmala Bhogal and Michelle Hudson of the Fund for the Replacement of Animals in Medical Experiments (FRAME) review the questions being raised on whether primate experimentation is in keeping with the current level of knowledge and the evolving healthcare market.  
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Labs & Logistics
Oliver Bohnsack of Perceptive Informatics illustrates how core imaging labs can improve quality in the imaging process through their infrastructure and by using regulatory guidelines to bring a level of harmonisation to image acquisition and interpretation.  
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With the capabilities of global networks stretched to the limit, Steve Giampapa and Rognvald Lamb of Fisher Clinical Services examine how organisations are adapting to these new circumstances, and suggest steps to maximise network performance in an environment of rapid-fire change.  
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