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International Clinical Trials

ict
Spring 2006
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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Regulatory & Business Practice
Although increasing regulation, globalisation and spiralling costs all threaten to have a destabilising effect, the dangers to pharma can be overstated. In Calling all Innovators, Ian Leake of BearingPoint insists it’s essential that the risk- and change-averse culture of ‘old compliance’ be discarded, and an ‘intelligent compliance’ culture fostered  
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The EU recognises HIV/AIDS, malaria and tuberculosis to be a major challenge, and that a response to their evolving nature and geographical spread within developing countries is urgently needed.Wim Van Velzen of Covington and Burling LLP assesses the valuable work of a new clinical trials partnership, in Legal Instrument Plays Sweetly  
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Clinical Trial Management
Every member of the clinical trial team plays a role in enhancing patient recruitment. In establishing a study-specific, patient-focused approach, Janet Jones at Kendle, and Val Lyness, former Chairman of the Institute of Clinical Research, believe Everybody Wins  
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Real-time management, review and integration of clinical trials data into a single database allows sponsors and their research partners to make timely,well-judged decisions about the conduct of clinical studies. John M Hudak at Criterium, Inc, embraces this more ‘agile’ approach, in Trials Limber Up  
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Unlike other revolutions, the rise of biomarkers appears to be largely free of detractors. It is then a question of the industry finding agreement on the route to implement change, as Lawrence K Oliver of Mayo Clinical Trial Services investigates, in Biomarkers – How to Manage a Revolution  
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Clinical trials represent the single largest cost for drug development – and patient recruitment is a key phase in the process. In Gaining Control, Dr Ian Smith of Synexus challenges pharma to radically rethink the way in which it recruits and retains patients  
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Global Outsourcing
Driven by the desire to control costs and increase investment returns, pharma looks to the developing world to conduct clinical studies. At the forefront of this growth market, reports Gary Muddyman of Conversis, is India – The New Tiger of Clinical Trials  
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Another Sunrise in Sight? With Asian and Latin American competitors hot on their heels, Sumanth Kambhammettu at Frost & Sullivan wonders whether India can maximise its reputation as the bright star in clinical trials outsourcing  
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eCLINICAL
It is vital for the successful management of a trial that there is a clinical operations manager in place to drive the implementation of EDC. In Strategic Interaction, Ian O’Shaughnessy at ICON Clinical Research considers how to harness the real benefits of eClinical  
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Don’t feel intimidated by the organisational and process issues in adaptive research, says Michael J Rosenberg of Health Decisions; in Adapting to Adaptive Studies, methods of delivering maximum benefits come under scrutiny  
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Graham Bunn at Medidata Solutions Worldwide explores the myriad considerations when conducting EDC-based trials in the Asia Pacific region, along with the advantages they can bring to large, remote trials that are often difficult to manage, in Pacific Overtures  
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Labs & Logistics
Seeking to vastly improve the overall management of the supply chain? Look no further – Jonathan Calderwood and Jim Murphy of Almac revere the qualities of IVRS, in A Fresh Approach to an Evolving Interface  
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The influx of EU regulations coming into force means that pharma must keep its eye on the ball and, as the third largest player in the medical devices market, German companies remain ever vigilant. In Deutsche on Devices, Andreas Grund and Judith Thevarajah of GCP-Service survey the scene  
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Critical Paths: The Stability Game – Mark Hammond and Carol Barbour of Melbourn Scientific explain that, by assessing dosage forms’ consistent potency and response to storage conditions, stability testing provides valuable support – from clinical development through to manufacture  
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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

Fifth Annual Peptides Congress: Registration Now Open

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White Papers

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Industry Events

Temperature Controlled Logistics 2018

29 January - 1 February 2018, Twickenham Stadium, London

Each January for the past 16 years, more than 400 senior supply chain, logistics, storage, regulation and quality experts from the pharmaceutical industry have gathered at the TCL Forum for the largest, longest running and most comprehensive cold chain and ambient logistics conference in Europe.
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