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International Clinical Trials

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Spring 2010
   
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Regulatory & Business Practice
Walter Janssens, Kristof Bonnarens and Greet Musch at the Federal Agency for Medicinal and Health Products, Belgium, outline the regulatory rules for exploratory clinical trials.  
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Trial Management & Outsourcing

Mario Tanguay of Anapharm looks at new strategies for designing and conducting Phase I studies which can help to streamline the early clinical drug development process.

 
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Having already been recognised and applauded for their achievements to date,Vanessa Poustie gives us an insight into what else to expect from the NIHR Medicines for Children Research Network as they work towards improving child health.  
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Planning for a clinical study is more than just determining the aim, as John Shillingford at Averion will tell you; in these times of financial crisis, the metrics – costs and timelines – of a study are just as crucial.  
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Scientists are probably not always best known for their communication skills, concealing inadvertently the very thing they mean to communicate. Julia Forjanic Klapproth and Barry Drees of Trilogy Writing & Consulting GmbH examine the role of the medical writer as a strategic partner on the clinical team.  
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Regional trials
Karen Politis Virk at Language Connections looks at the benefits of outsourcing clinical trial research to South Korea over other emerging markets, as well as the challenges faced by investigators.  
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If you’re thinking of conducting clinical trials in the Middle East and North Africa, Maha Al-Farhan of ClinArt International provides accurate up-to-date information about the laws and regulations in the region.  
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data management & statistical analysis
As the functional service provider (FSP) model increasingly replaces the traditional CRO paradigm for data management, Nelson Lee at the Society for Clinical Data Management reveals the elements needed for a successful FSP partnership.  
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John F Tomera at WorldCare Clinical illustrates how adaptive clinical trials may be the future of R&D – citing adaptive designs, interim analysis and imaging CROs as tools for ensuring more effective portfolio management.  
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Paula McHale at Perceptive Informatics explains why, despite the availability of electronic data capture technology, paper can be the best way to go on occasions. She provides guidelines for selecting a good hybrid tool that can manage both means of data collection.  
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With the recent financial pressures on the pharmaceutical clinical development process, Ed Krasovec of STARLIMS Corporation explores the use of Laboratory Information Management Systems as a solution to the problem – improving efficiency and reducing costs.  
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Drug delivery & Therapeutics
Intranasal drug delivery has always been a viable alternative to oral or subcutaneous routes for drugs with low bioavailability and, despite the challenges involved, recent developments have been eye-catching, explains Andrew Leary at Shandon Clinic.  
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