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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

Signant Health Launches Partner Program to Team with Clinical Research Organizations (CROs) Committed to Improving Clinical Trials with Patient-Centric Technology

PHILADELPHIA – August 12, 2019: Signant Health (signanthealth.com), a leading provider of technology for clinical research, today launches the Signant Health Partner Program, a significant investment the company is making to enable clinical research organizations (CROs) to better serve sponsors in the areas of Patient Data, Patient Experience, Clinical Supplies, and Endpoint Quality Solutions. By becoming a Signant Partner, CROs will benefit from new commercial and operational advantages that only come with membership.
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White Papers

Quality of Steel

Natoli Engineering Company, Inc.

Steel quality is the summation of how well a steel meets its specified chemistry, the cleanliness of the steel or degree to which it is free of impurities or inclusion, homogeneity of the microstructure, grain/carbide size and in some instances if it meets the mechanical requirements for that particular steel. In the design and manufacture of tablet compression tooling, nothing is more important than the quality of the materials being used. The best manufacturing principals maintaining the tightest tolerances will result in tool failure if the initial material quality is poor. Material quality is the fundamental building block upon which all successive value added steps are laid. The majority of all tablet compression tooling is produced from steel and steel quality is the subject of this article.
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Industry Events

SAPHEX 2019

23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA

SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention Centre, Johannesburg, South Africa.
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