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International Clinical Trials

ict
Autumn 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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Regulatory & Business Practice
Tim Worden of Taylor Wessing LLP discusses the MHRA’s investigation into GSK’s reporting of adverse events in Seroxat paediatric clinical trials  
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Sarah Powell at Liquent examines the results of a 2008 regulatory affairs trends survey of the pharmaceutical industry  
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The latest European Court ruling fails to resolve parallel trade uncertainty, reports Edward Miller of Reed Smith  
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Clinical Trial Management
Nicola Murgatroyd of Phlexglobal Ltd explains how finding and keeping people with the right skills, from secretaries to a highly experienced clinical research professionals, can energise a company  
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Angus Cameron at Pharmarama gives his advice on deploying comparator drugs in China for global clinical trials  
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Steve Toon of Simcyp Limited argues that the pharmaceutical industry must tap into the real value of modelling and simulation in drug ADME  
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Colin Garner and Graham Lappin at Xceleron explore safety testing of drug metabolites and look to gain a better understanding of human drug metabolism at an earlier stage  
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eCLINICAL
The convergence of electronic health records and clinical research is changing the way the pharmaceutical industry operates. Jacob Helton, Landen Bain and Rebecca Daniels Kush of the Clinical Data Interchange Standards Consortium (CDISC) and Linda King of Eli Lilly and Company investigate an evolving landscape  
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Urban Fröderberg of Anoto AB examines how digital pen and paper technology, as a relative newcomer among data capture tools, can help address some of the hurdles encountered by CROs  
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Robin Longdin of LCG Bioscience and Nick Townsend of LabWare Europe discuss the introduction of a new-generation laboratory information management system (LIMS) into a busy Phase I clinical trials facility  
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Portable software helps monitors manage site visits, validate protocol compliance, and assess the integrity of trial data, insists John Humphreys of Perceptive Informatics, a PAREXEL International company  
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THERAPEUTICS
Mike Wyllie of Plethora Solutions charts the trends in urological drug development – an untapped market where medical need is at present poorly met  
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Labs & Logistics
Don Riach at Marken reviews the challenges of transporting diagnostic blood samples back to central laboratories in a timely manner  
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Jeff Clark of BioStorage Technologies Inc reveals how in-home clinical trial service mitigates risk with a strategic, holistic approach to cold chain management  
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Natasha Molnár of SCA Cool Logistics asks whether it is possible to find a packaging solution which ticks all the right temperature-controlled boxes  
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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

MRC Technology monetises royalties on cancer drug Keytruda (pembrolizumab) to expand medical research activities, with a fund managed by DRI Capital


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White Papers

Biosimilars In Emerging Markets: Is It A Level Playing Field?

PRA Health Sciences (PRA)

Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need. At its best, the global expansion of biosimilars can mean a robust and steady supply of existing and new drugs reaching far-flung patient populations, but localized biosimilar drug developments, especially in China and India, combined with a lack of robust pharmacovigilance systems, threaten to derail the industry by putting patient health at risk.
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Industry Events

7th annual Orphan Drugs and Rare Diseases UK

18-19 October 2017, Holiday Inn Kensington Forum, London

SMi Group is thrilled to present the 7th annual Orphan Drugs and Rare Diseases conference, taking place on 18th & 19th October 2017 in Central London, UK. This year’s theme will be focused towards discussing strategies for patient engagement, market access and gene therapies to enhance rare diseases and orphan drug research.
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