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International Clinical Trials

ict
Spring 2008
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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Clinical Trial Management
Raising the Bar for patient recruitment methods has included the use of a comprehensive in-house database covering a wide range of countries and therapeutic indications.This method, which is increasingly being used by CROs, involves a more scientific and targeted approach and should become a new standard for best practice within the industry, argues Alan Morgan of ICON Clinical Research  
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Challenging current paradigms associated with automated cognitive testing within clinical trials,Mark Cusack of CDR looks at ways to employ the appropriate systems that can provide the industry with greater operational efficiencies, scientific insight, and Brain Power  
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The creation of data monitoring committees is almost a routine practice in randomised control trials that are performed specifically to register a human medicinal product. In Credible Risk Management, Gurdyal Kalsi of MDS Pharma Services assesses the value of data monitoring committees from the perspective of a CRO  
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MICRODOSING
David Edwards of Capsugel assesses the teething problems faced by those trying to introduce new drugs into the marketplace. The restriction of resources in early stage drug development, such as available drug quantities, testing personnel, equipment, funding and, perhaps most crucially, time, are all considered in Beyond Fast Filling  
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MEDICAL IMAGING AND QT STUDIES
The success of a trial, and ultimately clean study data, is determined during the initial stages of the process. In Sound Starts, Frank Dunn and Jeffery Bowden of Biomedical Systems discuss the question of logistics, and assess the safety and efficacy of a particular drug or medical device used in clinical trials  
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In Expect the Unexpected, Oliver Bohnsack and Manuela Lesch of Perceptive Informatics assert that in order to advance the procedure of clinical trials, dramatic improvements within medical imaging technologies are vital, as is the need to regularly review those directly involved in conducting the trials in order to provide consistent results  
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GLOBAL OUTSOURCING & REGULATORY COMPLIANCE
As the outsourcing scene opens up to emerging markets, pharmaceutical companies must make decisions about which of the key regions to focus on when it comes to clinical trials. Jerry Boxall of ACM-Pivotal Europe gets on the trail in Materialising Markets  
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Jaime Caro of United BioSource Corporation considers how Surmounting the Hurdles of New German Regulations will mean that companies can no longer leave the economics to Phase IV – early preparation is called for  
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In The Global Player, Nilesh Vite and Arulsingh Jayaraman of Lambda Therapeutic Research assess India’s role as a burgeoning player for the outsourcing of clinical trials,placing the focus on efficient subject recruitment and effective cost management  
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THERAPEUTICS
In The Fibrotic Process, William Rosenberg of University College London assesses the worldwide impact of chronic viral hepatitis, alcoholic liver disease and non-alcoholic fatty liver disease on the pharmaceutical and biotechnology industries in terms of their earning potential for new therapeutic interventions and diagnostic tests  
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As sleep medicine makes its mark on drug development in the pharmaceutical industry, Martin King of LCG Bioscience outlines some of the most common sleep disorders and their implications, and explains the techniques available for practitioners undertaking specialist sleep trials, in More Than a Sleeping Partner  
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Labs & Logistics
Global consolidation within the pharmaceutical industry is becoming increasingly necessary in the current economic climate. In Solid Supply, Chris Tierney at DHL Excel Supply Chain examines this shift alongside the need for cost reduction and service enhancement in what is a highly competitive industry  
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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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• DENARASE® is now available through VWR’s sales channels in Europe • VWR, part of Avantor, is a leading global provider of product and service solutions to laboratory and production customers • Cooperation harbors the potential for c-LEcta’s product to gain additional share in a highly dynamic market
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White Papers

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Clinical Professionals

Whilst the majority of Clinical Professionals clients are working to discover and develop innovative, cost effective medicines that address unmet medical needs they are not impacting the unmet needs of training and developing new recruits into the pharma industry. The impact is highlighted within entry level Clinical Trial Administrators and Clinical Research Associates (CTA/CRA). In the past the Pharmaceutical industry had highly developed training programs for these sought after candidates. As the use of outsourcing models and CRO’s has increased and fewer Pharma businesses embark on their own R&D a substantial gap is developing in newly trained Life Science graduates entering the market to commence a career within R&D. As further financial cuts are made within R&D spend this already dire situation continues to escalate.
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Industry Events

10th Annual Summit for Clinical Ops Executives

18-21 February 2019, Hyatt Regency Orlando, Florida

Celebrating its 10th successful year, SCOPE Summit 2019 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 19 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations, including...
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