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International Clinical Trials

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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

YHEC announces the promotions of Michelle Jenks and Rachael McCool to the role Project Director

YHEC is pleased to announce the promotions of Michelle Jenks from the Economic Modelling team and Rachael McCool from the Systematic Reviewing team to the role Project Director. Michelle has a Master’s degree (MSc) in health economics from the University of York and has conducted economic evaluations and systematic reviews for both public and private sector clients. Michelle is the lead modeller in YHEC’s role as an External Assessment Centre for NICE and has also led on a range of economic evaluations conducted for clients within industry, such as cost-utility models and budget impact models. She often leads the development of early economic analyses to inform clinical trial design and pricing strategy.
More info >>

White Papers

eSource: Reducing Site Workload for Better, Faster, Safer Clinical Trials

Clinical Ink

Unlike traditional electronic data capture (EDC), SureSource, Clinical Ink’s eSource platform, was designed from the beginning to minimize clinical trial complexity for site users. A Site Impact Survey provides scientific evidence regarding the impact of SureSource from 517 site users. Results confirm it significantly reduces workload, lessens queries, and improves data quality compared to paper and EDC. In this white paper, we quantitatively evaluate survey outcomes, provide qualitative feedback from survey respondents, and highlight the observed benefits of SureSource for transforming clinical research.
More info >>

Industry Events

12th Annual Parallel Trade

6-7 February 2018, Holiday Inn Kensington Forum, London, UK

SMi Group is proud to announce the return of Europe’s only Parallel Trade conference. Back for the 12thyear, Parallel Trade returns to London on 6th-7th February 2018.
More info >>

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