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International Clinical Trials

ict
Winter 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
As the pharma industry struggles to cope with the high rate of Phase III failures, Mike Macnamee of LCG Bioscience believes that it is crucial to use patients in the early stages of clinical research in order to grasp the opportunities created by more personalised and gene-specific therapeutics, in Patients Are a Virtue  
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Kenneth Getz at the Tufts Center for the Study of Drug Development, James Kremidas at Eli Lilly and Company, Elizabeth Carfioli of Ogilvy Healthworld Consulting (US) and Rachael Butlin at Fast4wD Ogilvy (UK) pursue ways in which to challenge and improve public perceptions of clinical research, in We Can be Heroes  
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In New Waves, Dr Timothy Callahan and Dr Pierre Maison-Blanche of Biomedical Systems put the spotlight on comprehensive training at investigative sites – a necessary step for ensuring that ECG data collected onsite is of a high quality, free of artifact and has minimal variability  
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Bruce Stouch at Premier Research explores the construct of asymmetrical boundaries for interim monitoring of a fixed design, as well as the design requirements for monitoring using a Bayesian approach, in Monitored Progress  
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eCLINICAL
Secure, private and of higher quality than paper diary records, eDiaries have finally entered the mainstream. In Regulating e-Diaries, Valdo Arnera and Stephen A Raymond of PHT Corporation reflect on the key regulations affecting eDiary systems and how their providers and sponsors should adhere to these rules  
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In Pharma Champion, Mark Penniston at Omnicare Clinical Research General notes that acceptance of CDISC has gained momentum over the past few years and has a very strong future, especially as regulatory bodies increase their usage of these standards  
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Clinical trials frequently rely on subjective clinician-rated outcomes as pivotal endpoints – thus missing out on electronic tools which can assist in reinforcing continuous data reliability. In Improving Ratings Precision, Oto Markovic and Rusty Bealer of United BioSource Corporation examine how these systems can be designed and deployed in support of clinical trials  
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Drug delivery & Therapeutics
Over the past year revenues from global clinical trials have increased by almost 15 per cent. Gary Muddyman of Conversis unpicks the Cultural Dimensions of running trials in emerging markets, outlining the need to avoid stumbling blocks such as differing clinical trial demands in disparate locales, varied sales and distribution channels, the coordination of simultaneous launches to market, and drug cloning and counterfeiting  
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Having overcome a recent spot of trouble, Russia’s role in the development of international clinical trials in Central and Eastern Europe looks increasingly promising; whilst the emergence of Ukraine, Belarus and Kazakhstan in the trials arena in 2008 will be one to watch out for, opines Irina Dobreva of Congenix in Research Reaches Beyond Borders  
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Shifting pharmacovigilance and clinical data management work abroad is allowing pharmaceutical firms to maximise R&D and push drugs to market more effectively – Charles Arnold and Vicki Tauscher Phelan of EquaTerra investigate The New Frontier in outsourcing  
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Labs & Logistics
In The Power of Communication, Mark Woolf of Almac Clinical Services explores the complex challenges faced by distribution managers surrounding the shipping of clinical trials materials to emerging markets  
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The temperature-sensitive nature of numerous drugs and the importance of achieving reliable test results make it particularly important that drugs arrive at their destination with their integrity intact. Geraint Thomas of Laminar Medica points to the advantages of careful planning and investment in the latest technology during shipping, in The Trials of Temperature Control  
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
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News and Press Releases

Nemera organized an expert review on the present and future of inhalation products

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White Papers

Delivering Fit For Purpose Biomanufacturing CHO Cell Lines

Fujifilm Diosynth Biotechnologies

The challenge during mammalian cell line development is to identify and isolate stable, high expressing cell lines producing product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Obtaining a host cell line that inherently exhibits desirable biomanufacturing attributes can therefore have a significantly positive effect on the identification of recombinant cell lines with desired traits during cell line development screens. In this study, we demonstrate that it is possible to exploit intrinsic heterogeneity within host cell populations and identify host cell lines which are more “fit for purpose”.
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Industry Events

SMi Presents the 13th Annual Conference: Parallel Trade 2019

5-6 February 2019, Holiday Inn Kensington Forum, London

SMi presents its 13th annual Parallel Trade conference, taking place in London on the 5th-6th of February 2019. As the only parallel trade conference in Europe, this event provides the perfect platform for industry experts from both sides of the coin to come together and share perspectives on the practice of parallel trade.
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