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International Clinical Trials

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Summer 2010
   
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Regulatory & Business Practice
John Lewis of the Association of Clinical Research Organizations assesses recent findings demonstrating the effects of culturally specific regulations on patient participation, and the hidden burden facing physicians.  
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Past mistakes should be avoided through researching sources carefully and developing strong foundations for dialogue. Hugh Davies of the National Research Ethics Service presents an approach to utilise resources when reviewing the ‘facts’ more efficiently.

 

 
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Incorporating the planning of integrated summaries from the beginning of the process of a product’s approval can avoid a lack of clarity when making key decisions; Michael Whitworth from Quanticate investigates.  
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TRIAL MANAGEMENT
Pharma companies now spend up to 60 per cent of their R&D capital on clinical trials and make significant losses each day that there’s a setback. As patient participation is one of the principal factors that can lead to such delays, Benjamin Jackson of Quartesian recommends internet-based recruitment as a targeted way of finding willing patients.  
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Kim Boericke at i3 Research and Bill Gwinn at i3 Pharma Informatics discuss the importance of protocol design, country and site selection, investigators’ experience and patient recruitment before the start of any study to ensure a speedy conclusion.  
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James McRedmond of Java Clinical Research points out that the pharmacodynamic effects of a drug is what allows for better decision-making in the clinical development process, and draws attention to how one can improve the accuracy and quality of the data obtained.  
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Despite shrinking budgets the late phase research sector grew last year, seeing global outsourcing rise and post-market surveillance increase. David Selkirk of Omnicare Clinical Research asserts how late phase research can continue to provide benefits to the industry as a whole.
 
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Regional trials
As Latin America becomes an increasingly popular destination for clinical trials – with the number of studies conducted in the region expected to increase by an average of 20 per cent each year – Fernanda C Durán and Valeria Francesconi at PharmaNet Development Group consider the potential benefits and challenges for companies considering this move.  
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eCLINICAL, DATA MANAGEMENT & STATISTICAL ANALYSIS
As well as embracing and adapting to new technologies, pharma companies need to remember that no solution is effective in isolation. Jim DeSanti of PharmaVigilant explains how EDC and EMR systems can work together to achieve more efficient results.  
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How organised are you when it comes to creating internal documents with several inputs – who is doing what, when, and on which version of the file? Kris Sæther and Andreas Jordell at Xait suggest ways to ensure constructive collaboration.  
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Christina Hughes and Kimberly Foulds at United BioSource Corporation explore ways of reducing variability in clinical data due to subjective endpoints, focusing on video surveillance and how this method can actually improve the overall quality of data accrued.  
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DRUG DISCOVERY & DELIVERY
It is estimated that 70 per cent of new chemical entities entering drug development programmes are unable to undergo sufficient gastrointestinal absorption to ensure efficacy. John McDermott of Quotient Bioresearch believes that early screening of prototype formulations is beneficial to avoid delays to the process.  
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James Blakemore and Brennan Miles of Team Consulting Ltd discuss the importance of considering medical device function and design during the concept generation stage – pointing out that, in the end, the suitability of the overall product to the user is what will determine the level of the drug’s commercial success.  
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Labs & Logistics
With testing options changing constantly, and protocols becoming more complex, central labs have a pivotal role to play in the conduct of clinical trials. Elena Logan of ACM Global Central Lab considers how outsourcing will continue to affect lab testing.  
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Reflecting on the evolution of the central laboratory, Thomasz Anyszek of LabConnect Europe and Synevo Central Laboratory, and Eric Hayashi and Frank D Morrow of LabConnect, LLC discuss the ongoing advantages and disadvantages of local and central frameworks.  
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As the possibility of integrating emerging markets into clinical research supply chains increases, Alex Klim and Eddie Aston of DHL Supply Chain offer an insight into the potential obstacles that lie ahead.  
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August and November

News and Press Releases

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White Papers

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Industry Events

12th annual Cold Chain Distribution Conference and Exhibition

13-14 December 2017, Copthorne Tara Hotel, London, UK

Responding to the evolution within the industry, SMi is proud to announce the return of its leading 12th annual Cold Chain Distribution event. Returning to London in December, this year's event will remain at the forefront of innovation
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