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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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News and Press Releases

AirBridgeCargo Airlines Expands Its Partnership With Sonoco Thermosafe To Embrace New Pegasus Uld Passive Container

AirBridgeCargo Airlines, part of Volga-Dnepr Group, expands its Master Lease Agreement with Sonoco ThermoSafe to enable its customers worldwide to transport life-saving and healthcare products within Pegasus ULD passive container (passive container – ULD capable to maintain internal temperature environment during a certain period of time without charge). The latest Sonoco addition to a sophisticated product family will guarantee secure, trackable, and reliable transportation of temperature-sensitive pharmaceutical shipments of up to 998 kg.
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White Papers

Biosimilars In Emerging Markets: Is It A Level Playing Field?

PRA Health Sciences (PRA)

Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need. At its best, the global expansion of biosimilars can mean a robust and steady supply of existing and new drugs reaching far-flung patient populations, but localized biosimilar drug developments, especially in China and India, combined with a lack of robust pharmacovigilance systems, threaten to derail the industry by putting patient health at risk.
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