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European Pharmaceutical Contractor

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Winter 2012

   
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Marketplace & Business
Active Investigators

A Drop in Numbers

Karyn Korieth and Annick Anderson at CenterWatch examine the decrease in the number of active investigators in western Europe, looking at some possible causes. In this article they consider whether it can be attributed to the financial crisis or is simply a shift in cultural attitudes.
 
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Regional Focus: Japan

The New Far East

Geetika Munjal at GBI Research focuses on the changes that are predicted in Japan over the coming years, looking at some of the problems to be addressed along the way, and considers the region’s potential for viable partnerships.
 
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Emerging Markets

Shifting Sands

As pharmaceutical spending in emerging economies increases, what will be the consequences for the established market? Chantal Williams at RSA delves into the world of ‘pharmerging markets’ and speculates on what the future may hold.
 
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Clinical Trials
Clinical Trials: Monitoring

Assessing Suicide Risk

Treatment-emergent suicidality in patients involved in clinical trials is gradually becoming more prominent. Michael Federico at ERT sets out the possible contributing factors, as well as methods to overcome the problem.
 
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Clinical Trials: Risk-Based Monitoring

Sites Unseen

Monitoring is essential when considering clinical trials research data. Rick Morrison of Comprehend Systems believes that ‘technology as innovation’ will continue to affect the industry.
 
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Paediatric Programmes

Youth Investment

Colin Hayward of Premier Research explores the area of paediatric clinical trials and the problems they face, including availability of patients and a lack of expertise in this practice.
 
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Legal & Regulatory
Anti-Bribery Legislation

Removing Incentives

The recently introduced UK Bribery Act has prompted many sectors, including the pharmaceutical industry, to modify the way in which they function. Laurent Clerc at BMI SYSTEM and Steven Gray at Compliance Hub outline the range of effects this new legislation is having on Big Pharma.
 
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Anti-Bribery Legislation

Risky Business

Keith M Korenchuk and Silvia Valverde at Arnold & Porter LLP outline the UK’s anti-bribery landscape from a legal perspective, and provide practical tips to ensure that pharma companies adhere to the updated regulations.
 
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Regulatory: Electronic Clinical Trials

Investigating the Investigators

As our world moves away from paper and becomes ever more technology-reliant, what measures can we put in place to check that the information gathered is as precise as possible? Chris Cramer at Quanticate considers the chain of accountability.

 
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Reviews & Previews
Event Review

Too Focused on Patients?

Graham Hughes reviews the DIA Clinical Forum that took place in October in The Hague, and raises the question of whether we are too focused on patients and are neglecting wider clinical research concerns.
 
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DATA MANAGEMENT
Streamlined Solutions

Calm in the Chaos

Although technology is necessary in order for processes to be streamlined and efficient, when it becomes too complex, problems can arise. Bill Byrom at Perceptive Informatics explains how amalgamating multiple functions can help to alleviate this issue.
 
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Review
Editor’s Letter

Graham Hughes outlines some of the crucial changes happening both in the pharma world and here at Samedan Ltd.
 
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Cool Chain, Labs & Logistics
Cold Chain Technology

A Leap of Faith

The effects of temperature and altitude on a shipping container can mean the difference between success and failure. Alex Roskoss at Intelsius uses a well-known analogy to illustrate how detrimental it could be to overlook the finer details.
 
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Medical Writing
Product Packaging

Multi-Language Labelling

As the pharmaceutical industry becomes more global in its operations, also taking into consideration the plethora of different languages to cater for, Neil Gleghorn at Kallik proposes a more integrated, culturally-aware approach to product labelling.
 
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Interview
Interview: Nadia Cheaib

Changing Perspectives

Increasingly, the MENA region is becoming a big player in the global clinical trials arena. Nadia Cheaib at ClinServ talks to EPC about why this is the case, and what may occur over the next 12 months.

 

 


 
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Interview: Simon Saxby

Looking Back, Looking Forward

Simon Saxby at Selcia summarises 2012 and shares his predictions for the year ahead.
 
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