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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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February, May,
August and November

News and Press Releases

Bigneat is awarded the Queen’s Award by Lord-Lieutenant of Hampshire

Bigneat Ltd, winner of a Queen’s Award for Enterprise earlier this year, received their Award from Nigel Atkinson Esq, HM Lord-Lieutenant of Hampshire on 16th October at the Bigneat factory in Waterlooville.
More info >>

White Papers

PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content

Phlexglobal Ltd

Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive. As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
More info >>

Industry Events

11th Annual Proteins & Antibodies Congress

16-17 April 2018, Novotel London West Hotel, Hammersmith, London

Oxford Global Conferences are proud to present our esteemed 11thAnnual Proteins & Antibodies Congress 2018, 16th – 17th April 2018, London, UK. Over 450 proteins, antibodies, peptides and biosimilars & biobetters attendees representing global pharmaceutical organizations, leading biotech companies and internationally renowned academic institutions.
More info >>

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