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International Clinical Trials

ict
Summer 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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eCLINICAL
Observational studies may be common in epidemiological investigations, but Dominic Farmer of Cisiv illustrates how these studies, combined with web-enabled technologies, are ideally positioned to act as the bridge between pharma companies, patients, physicians and regulators.  
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John Blakeley of ERT tackles the issue of suicidality in clinical trials, and explains how electronic patient reported outcome tools are being used to increase the efficiency and accuracy of the monitoring process.  
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MEDICAL IMAGING AND QT STUDIES
As the value of operational and clinical metrics increases with time, global sponsors must work to engage CROs with the appropriate internal metrics and outsourcing approach to handle complex trials at the outset of the study; Richard Walovitch and Asli Memisoglu of WorldCare Clinical discuss.  
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While the pharmaceutical industry has rightly placed an emphasis on the significance of TQT studies, the fixation on demonstrating a negative signal has clouded the fact that these studies are only one part of the development programme of an NCE. Jörg Täubel and Keith Berelowitz at Richmond Pharmacology remind us of the three core elements of a successful TQT study.  
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Trial Management & Outsourcing
As recently as two decades ago, clinical trials were conducted almost exclusively in developed countries. Today, however, Latin America is widely recognised for its large number of treatment-naive subjects, qualified investigators, established regulatory systems and reasonable costs, as Victor Molina-Viamonte of Omnicare Clinical Research reports.  
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Getting to grips with translation can not only improve the quality of clinical research, but should also reduce the time to market for drugs by ensuring compliance with regulatory requirements; Steve Wilde of The Translation People explains more.  
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With clinical trials in China estimated, on average, to cost just 20 per cent of those in the West, many view the the country as the most attractive low-cost clinical trial location outside the US. Susan Wang of MDS Pharma Services investigates the current status of early stage capabilities in China.  
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In the current marketplace, global pharmaceutical and medical technology companies face many financial and organisational challenges; Brenda Hoeper and Cathy Thompson at i3 highlight the advantages of establishing a strategic alliance, and provide the building blocks for a successful, highly productive relationship.  
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As the recession bites, the focus of many organisations turns to cost savings, with outsourcing widely seen as a potential panacea. However, failing to invest in management structures, relationship-building and innovation can mean that outsourcing arrangements do not deliver the desired savings and profits, warn Jonathan Cooper-Bagnall and Kevin Deane of PA Consulting Group.  
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Ethics & Risk Management
With the pressure to produce results mounting on those organisations sponsoring and conducting clinical research projects, Frank Wells at the EFGCP asserts the need for an endorsed mechanism to investigate allegations of research misconduct, and to decide how national advisory bodies can best contribute to that mechanism.  
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Kathy Burns of Aon discusses the role that technology, and a risk management information system in particular, can play in streamlining the launch and management of clinical trials, as well as creating a holistic approach to managing risk.  
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Drug delivery & Therapeutics
Sandra Hageman and Edwin Janssen at Eurofind Medinet outline how detecting and characterising wanted and unwanted immune responses to new biopharmaceuticals is an essential task in order to ensure clinical trial safety and efficacy.  
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It is now possible to combine a single clinical study so that PET imaging can be obtained along with pharmacokinetic data, thus maximising the data output from a single trial, which in turn allows for a cost-effectived design explain Graham Lappin and Marie Simpson at Xceleron, and Oliver Langer, Department of Clinical Pharmacology, the Medical University of Vienna.  
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Labs & Logistics
Martin Crockard at Randox explains how finding the right quality control scheme is determined by the size, duration and complexity of each trial, and shows how a suitable control can be selected to fit every test.  
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The process of identifying a sourcing provider for a comparator is detailed and complex; Lekishia White of Multipharma, Inc explores the uniqueness of the comparator as a commodity, and the selection criteria for choosing the right provider.  
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The question of how best to deal with the pharmaceutical quality and CMP of the investigational product in an early stage of CMC development has received little coverage. Berend Oosterhuis and Arjen Akkerman of PRA International outline why the manufacture of a drug product for early exploratory studies should occur in a flexible, small-scale unit at the site of the clinical study.  
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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

NDA Group Releases Data Comparing FDA and EMA Ahead of Annual DIA Europe in Basel

Today NDA Group announced their findings from its fifth annual comparison of drug approvals in Europe and the United States, in preparation for this year’s DIA Europe in Basel, Switzerland. The figures highlight the continued differences between the two regions, and the need for a global approach to drug development to ensure success across both continents.
More info >>

White Papers

The Flexible Factory Concept: A flexible bioprocessing platform to meet the changing needs of biomanufacturing

GE Healthcare Life Sciences

For the past several years, the biopharma industry has been buffeted by dynamic market conditions that are rapidly reshaping manufacturing requirements. These factors include: • The rise of small-market pharmaceuticals that do not require the production scale of the previous “blockbuster” drug model • Increased titers and process productivity that generate more bulk-product within a much smaller manufacturing footprint • The emergence of biosimilars and continued evolution of healthcare reform, which will increasingly pressure drug pricing and require greater cost discipline • Greater competition and shorter patent protection timelines, which will further ratchet up time-to-market pressures • Tighter capital markets that will create heightened scrutiny for all new investment projects
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Industry Events

Temperature Controlled Logistics in Biopharmaceuticals USA 2018

24-25 April 2018, Princeton, USA

After an extremely successful first edition, Temperature Controlled Logistics in Biopharmaceuticals is back in Princeton in April 2018!
More info >>

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