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PUBLICATIONS

International Clinical Trials

ict
Winter 2009
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
As clinical trial locations go global, the level of risk grows proportionally. James Walters of Aon Risk Services presents strategies to ensure the successful launch of a trial.  
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John Wilkinson of Reed Smith examines the regulations in the UK surrounding human embryonic stem cell therapies.  
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TRIAL MANAGEMENT
With the decline in development productivity, Alistair Sinclair of Datamonitor discusses how technical collaborations can optimise R&D strategies.  
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Xunting Zeng at InCROM explains how the revision of Chinese regulations has necessitated a streamlined system that aims to encourage innovation.  
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South and Central America is attracting attention as an evermore important area for clinical research. Gabriela Rácaro at PAREXEL International analyses the evolution that has taken place over the last decade.  
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Companies are turning to 'smart' technologies in order to improve productivity. Ed Seguine of Medidata Solutions believes that eProtocol will rejuvenate the industry.

 
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eCLINICAL
Robyn Roper at Wolters Kluwer Health argues that improving the process of collating, validating and interpreting clinical data will increase trial transparency.  
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Internet connectivity levels in Africa are extremely low, making it difficult to implement EDC in clinical trials - yet thinking outside the box and utilising different technologies may be the answer, points out Richard Young at Cmed.  
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Dacid Stein of Perceptive Informatics calls on eClinical integration improvements – a vital step if biopharmaceutical companies are to succeed in their competitive marketplace.  
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Ed Krasovec of STARLIMS Corporation sets out guidelines on implementing a unified informatics platform in order to manage laboratory operations in accordance with protocol and regulatory requirements  
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Maintaining volunteers' safety remains of paramount importance in clinical trials. Philippe L'Hostis of Biotrial examines the advantages of using digital ECGs during studies.  
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THERAPEUTICS
Fred Pritchard at MDS Pharma Services describes the challenges facing studies of Alzheimer's disease and the steps that can be taken to overcome them.  
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Spirometric data must be precise in order to ensure it is of the highest quality. Aleck Harrison at AJH Partners outlines the four main variables that can affect the results.  
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Labs & Logistics
Translating trial questionnaires is a complex and delicate process. Simon Andriesen at MediLingua highlights the guidelines that currently exist and some of the key issues to consider.  
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With an increasing number of products demanding cold chain shipment, a close partnering between sponsors, contractors and technology specialists is required, explain John Engelhardt and Keren Winmill at Penn Pharma.  
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Jonathan Calderwood of Almac Group examines the fundamental components of an efficient and cost-effective cold chain process.  
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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

BioIVT Acquires Optivia Biotechnology, Adding Transporter Assay Products and Services to its ADME-Tox Portfolio

BioIVT, a leading provider of research models and services for drug development, today announced that it has acquired Santa Clara, CA-based Optivia Biotechnology and its comprehensive portfolio of transporter assays, multi-transporter models, transporter systems biology, and molecular transport research solutions.
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White Papers

Cleaning Validation: What do you need to consider to ensure a successful outcome?

RSSL

Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination. The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support. The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues. So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
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Industry Events

SMi’s 9th Annual Biosimilars & Biobetters Conference

25-27 September 2018, Copthorne Tara Hotel, London, UK

Following the success of our previous events in both London and the US, Biosimilars and Biobetters UK 2018, SMi deliver a stellar speaker line-up and bring together a global audience of biosimilar experts to discuss the latest developments and future of the rapidly evolving and expanding biosimilars market.
More info >>

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