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International Clinical Trials

ict
Spring 2009
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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TRIAL MANAGEMENT
The effects of the recession and the prospect of thinning pipelines are major concerns for pharmaceutical companies; Sriram V of Frost & Sullivan discusses the long-term outlook for CROs.  
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Nicola Murgatroyd at Phlexglobal examines the importance of the role of clinical research associate and looks at the reasons why the industry is facing a shortage of candidates.  
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The increasing number of clinical trials being performed in developing economies has made high quality translation more important than ever, argues Mimi Maeda-Nye of TJC Global.  
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eCLINICAL
James Trammel at i3 Statprobe underlines the value of adaptive randomisation, explaining the methods that can be used to guarantee the validity of statistical conclusions.  
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In the context of the dramatic increase in the number of late-phase clinical trials worldwide, Kate Trainor of PAREXEL International looks at how the right technology can make a major difference in Phases IIIb and IV.  
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Tim Davis of Exco InTouch reflects on the immense popularity of SMS communication, and explains how text messaging technology can increase recruitment, retention and compliance in clinical trials  
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A well-integrated laboratory information management system, with the flexibility to work with an adaptive trial design, greatly increases the ability to get specimen handling, testing and reporting 'right first time', says Ed Krasovec of Starlims.  
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Regional trials
For clinical research conducted in developing countries, ethical concerns are a particularly salient issue. Harald Schmidt of the Nuffield Council of Bioethics and Peter G Smith of the London School of Hygiene & Tropical Medicine review the 2008 Declaration of Helsinki.  
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THERAPEUTICS
In light of the tough economic times, Richard N Williams of INC Research looks at how value can be maximised and drug development accelerated by embracing fresh regulatory initiatives.  
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Beata Paluchowska of Omnicare Clinical Research describes how the challenges involved in clinical trials for cancer drugs can be overcome by means of collaboration with oncology communities and experts from different fields.

 
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Jan Vertommon at Capsugel explains how enhanced bioavailability can improve the quality of data obtained from first-in-human clinical trials and evaluates the ways in which this can be achieved.  
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Nick Charles of Mayo Clinic presents a case study on the benefits of running a collaborative trial for Graves' ophthalmopathy.  
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Labs & Logistics
Jeffrey Litwin of ERT Inc looks at the critical role of central core labs in performing thorough ECG analysis.  
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Nick Townsend of LabWare explains why configurable LIMS with purpose-built modules are an asset for clinical trials, and looks at the options available when choosing a LIMS product.  
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As the focus of clinical trial activity shifts towards Asia, Robert Scott-Edwards of ICON Central Laboratories investigates the opportunities and challenges in India.  
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Geraint Thomas at Laminar Medica outlines the factors to consider when developing a passives cooling system which offers protection while meeting all relevant laws, regulations and guidelines.  
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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

POP TEST ADDRESSES THE PROBLEM OF UNRELIABLE DATA FROM CONTINUOUS GLUCOSE MONITORS

A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6 Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
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White Papers

The Key To Tableting Success: How To Choose The Right Tooling

Natoli Engineering Company, Inc.

Choosing the right tooling can increase tablet output, decrease waste and ultimately determine the success of a product launch.
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Industry Events

Automatica 2018

18 June 2018, Messe München, Munich, Germany

Automatica is the leading exhibition for smart automation and robotics. It features the world's largest range of robotics, assembly systems, machine vision systems and components. For more information go to automatic-munich.com/visitors
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