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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,
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News and Press Releases

BioIVT Acquires Optivia Biotechnology, Adding Transporter Assay Products and Services to its ADME-Tox Portfolio

BioIVT, a leading provider of research models and services for drug development, today announced that it has acquired Santa Clara, CA-based Optivia Biotechnology and its comprehensive portfolio of transporter assays, multi-transporter models, transporter systems biology, and molecular transport research solutions.
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White Papers

Securing the Global Pharmaceutical Supply Chain against the Threat of Counterfeit Drugs

World Courier

With a fully integrated GxP-compliant transport, storage and distribution system in place and over 140 wholly owned ISO 9001 - certified offices in more than 50 countries, WORLD COURIER, an AmerisourceBergen® company, is the world’s largest and most experienced provider of specialty courier services. It is uniquely positioned to meet the most demanding industry requirements for managing the global distribution of time - and temperaturesensitive pharmaceutical products and IMPs used commercially or in clinical trials.
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Industry Events

SMI Immuno-Oncology Conference

25-27 September 2018, Copthorne Tara Hotel, London, UK

Immuno-Oncology is a fast-paced field with massive potential to deliver successful and durable cancer therapies, and SMi's Immuno-Oncology Conference will focus on a few key areas of the field with a representation of the whole industry under each area. These areas will be drawn together to look towards the future of Immuno-oncology and how the field can progress.
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