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International Clinical Trials

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Autumn 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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Regulatory & Business Practice
Tim Worden of Taylor Wessing LLP discusses the MHRA’s investigation into GSK’s reporting of adverse events in Seroxat paediatric clinical trials  
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Sarah Powell at Liquent examines the results of a 2008 regulatory affairs trends survey of the pharmaceutical industry  
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The latest European Court ruling fails to resolve parallel trade uncertainty, reports Edward Miller of Reed Smith  
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Clinical Trial Management
Nicola Murgatroyd of Phlexglobal Ltd explains how finding and keeping people with the right skills, from secretaries to a highly experienced clinical research professionals, can energise a company  
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Angus Cameron at Pharmarama gives his advice on deploying comparator drugs in China for global clinical trials  
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Steve Toon of Simcyp Limited argues that the pharmaceutical industry must tap into the real value of modelling and simulation in drug ADME  
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Colin Garner and Graham Lappin at Xceleron explore safety testing of drug metabolites and look to gain a better understanding of human drug metabolism at an earlier stage  
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eCLINICAL
The convergence of electronic health records and clinical research is changing the way the pharmaceutical industry operates. Jacob Helton, Landen Bain and Rebecca Daniels Kush of the Clinical Data Interchange Standards Consortium (CDISC) and Linda King of Eli Lilly and Company investigate an evolving landscape  
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Urban Fröderberg of Anoto AB examines how digital pen and paper technology, as a relative newcomer among data capture tools, can help address some of the hurdles encountered by CROs  
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Robin Longdin of LCG Bioscience and Nick Townsend of LabWare Europe discuss the introduction of a new-generation laboratory information management system (LIMS) into a busy Phase I clinical trials facility  
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Portable software helps monitors manage site visits, validate protocol compliance, and assess the integrity of trial data, insists John Humphreys of Perceptive Informatics, a PAREXEL International company  
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THERAPEUTICS
Mike Wyllie of Plethora Solutions charts the trends in urological drug development – an untapped market where medical need is at present poorly met  
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Labs & Logistics
Don Riach at Marken reviews the challenges of transporting diagnostic blood samples back to central laboratories in a timely manner  
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Jeff Clark of BioStorage Technologies Inc reveals how in-home clinical trial service mitigates risk with a strategic, holistic approach to cold chain management  
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Natasha Molnár of SCA Cool Logistics asks whether it is possible to find a packaging solution which ticks all the right temperature-controlled boxes  
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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

Northway Biotechpharma Celebrates 15 Years of Growth and Success

Vilnius, Lithuania, July 16, 2019 ─ Northway Biotechpharma, a leading biopharmaceutical contract development and manufacturing organization (CDMO), celebrates its 15th anniversary today. As a midsized CDMO, Northway Biotechpharma is able to provide flexibility and responsiveness backed by a strong foundation in science and technology. The company focuses on understanding its customers and meeting their specific needs without binding them to one single approach. It is able to react rapidly to unexpected project changes, adjusting timelines, capacities and other activities to meet its customers’ evolving needs. On average, Northway Biotechpharma has 25–30 development projects underway each year, ranging from gene cloning to final drug product manufacturing.
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White Papers

Working Towards a Standardised Identification Solution

PCI Pharma Services

The security of the pharmaceutical supply chain is an issue of growing concern, with recent reports addressing its vulnerability to counterfeiting. The complexity of the European supply chain is one of the key factors of this counterfeiting pandemic, with millions of medicine packs being moved around the EU, annually. Aside from this, fragmentation has resulted in decreased transparency in the supply chain and increased difficulties to track and trace medicines, leading to significant threat from counterfeiting. As a key source of income for the European economy, it is essential that the supply chain remains safe and free of counterfeits. A significant stumbling block within the industry remains to be the lack of a unified, single‐source pan‐European or indeed global database where scanned bar codes on drug packaging can be verified at point of dispense. At some point in the future the pharmaceutical industry, regulatory bodies, clinicians and retailers will need to join forces to overcome this.
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Industry Events

CPhI & P-MEC India

26-28 November 2019, India Expo Centre, Greater Noida, Delhi NCR, India

As the pharma industry looks increasingly towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At CPhI & P-MEC India, you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business.
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