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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

With Help of DC-Based FDA Consulting Firm, Baltimore Nonprofit Helps Minority Students Achieve Careers in STEM Fields


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White Papers

The Key To Tableting Success: How To Choose The Right Tooling

Natoli Engineering Company, Inc.

Choosing the right tooling can increase tablet output, decrease waste and ultimately determine the success of a product launch.
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Industry Events

Pharmaceutical Microbiology East Coast

13-14 November 2017, Renaissance Woodbridge Hotel, New Jersey

Drawing on from the huge success of SMi’s Pharmaceutical Microbiology event series, SMi is delighted to announce the launch of Pharmaceutical Microbiology East Coast. Being the eighth in its series, this event will take place in New Jersey, USA, on November 13th and 14th 2017. Aimed at Microbiologists, Quality Control and Quality Assurance Managers, Pharmaceutical Microbiology East Coast 2017 will address the best practices for rapid microbial and sterility testing and tackle the challenges of contamination control.
More info >>

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