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International Clinical Trials

ict
Winter 2008
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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Clinical Trial Management
As the pharma industry struggles to cope with the high rate of Phase III failures, Mike Macnamee of LCG Bioscience believes that it is crucial to use patients in the early stages of clinical research in order to grasp the opportunities created by more personalised and gene-specific therapeutics, in Patients Are a Virtue  
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Kenneth Getz at the Tufts Center for the Study of Drug Development, James Kremidas at Eli Lilly and Company, Elizabeth Carfioli of Ogilvy Healthworld Consulting (US) and Rachael Butlin at Fast4wD Ogilvy (UK) pursue ways in which to challenge and improve public perceptions of clinical research, in We Can be Heroes  
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In New Waves, Dr Timothy Callahan and Dr Pierre Maison-Blanche of Biomedical Systems put the spotlight on comprehensive training at investigative sites – a necessary step for ensuring that ECG data collected onsite is of a high quality, free of artifact and has minimal variability  
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Bruce Stouch at Premier Research explores the construct of asymmetrical boundaries for interim monitoring of a fixed design, as well as the design requirements for monitoring using a Bayesian approach, in Monitored Progress  
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eCLINICAL
Secure, private and of higher quality than paper diary records, eDiaries have finally entered the mainstream. In Regulating e-Diaries, Valdo Arnera and Stephen A Raymond of PHT Corporation reflect on the key regulations affecting eDiary systems and how their providers and sponsors should adhere to these rules  
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In Pharma Champion, Mark Penniston at Omnicare Clinical Research General notes that acceptance of CDISC has gained momentum over the past few years and has a very strong future, especially as regulatory bodies increase their usage of these standards  
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Clinical trials frequently rely on subjective clinician-rated outcomes as pivotal endpoints – thus missing out on electronic tools which can assist in reinforcing continuous data reliability. In Improving Ratings Precision, Oto Markovic and Rusty Bealer of United BioSource Corporation examine how these systems can be designed and deployed in support of clinical trials  
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Drug delivery & Therapeutics
Over the past year revenues from global clinical trials have increased by almost 15 per cent. Gary Muddyman of Conversis unpicks the Cultural Dimensions of running trials in emerging markets, outlining the need to avoid stumbling blocks such as differing clinical trial demands in disparate locales, varied sales and distribution channels, the coordination of simultaneous launches to market, and drug cloning and counterfeiting  
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Having overcome a recent spot of trouble, Russia’s role in the development of international clinical trials in Central and Eastern Europe looks increasingly promising; whilst the emergence of Ukraine, Belarus and Kazakhstan in the trials arena in 2008 will be one to watch out for, opines Irina Dobreva of Congenix in Research Reaches Beyond Borders  
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Shifting pharmacovigilance and clinical data management work abroad is allowing pharmaceutical firms to maximise R&D and push drugs to market more effectively – Charles Arnold and Vicki Tauscher Phelan of EquaTerra investigate The New Frontier in outsourcing  
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Labs & Logistics
In The Power of Communication, Mark Woolf of Almac Clinical Services explores the complex challenges faced by distribution managers surrounding the shipping of clinical trials materials to emerging markets  
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The temperature-sensitive nature of numerous drugs and the importance of achieving reliable test results make it particularly important that drugs arrive at their destination with their integrity intact. Geraint Thomas of Laminar Medica points to the advantages of careful planning and investment in the latest technology during shipping, in The Trials of Temperature Control  
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

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News and Press Releases

When space is tight

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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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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!
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