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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

Avacta and Cytiva collaborating on COVID-19 rapid test

Cambridge and Wetherby, UK, 08 April 2020: Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, is pleased to announce that it has entered into a collaboration with Cytiva, formerly known as GE Healthcare Life Sciences. The companies will develop and manufacture an Affimer-based point-of-care rapid test intended for screening of large populations to diagnose the COVID-19 coronavirus infection.
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White Papers

Orthogonal Approaches for the Analysis of Protein Sequence

Ludger Ltd

One of the most important classes of biopharmaceuticals is monoclonal antibodies. They are expressed from living cells, and are consequently subject to complex biochemical pathways. Not all of these routes are fully understood, and many are sensitive to the subtlest of environmental changes. Changes such as these can affect the final biopharmaceutical sequence, structure and post-translational modifications, not to mention any changes that may occur during further purification. This often means that the final product from one batch may be different from the last in another batch. Each batch is a complicated mix of similar molecules, and analysis of the degree of batch-to-batch variation is therefore very important to the establishment of the drug's safety for medicinal use and patient administration.
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Industry Events

Formulation and Drug Delivery Series UK

8-9 July 2020, Oxford Global

This event brings together leading formulation, drug delivery and biologics manufacturing experts from around the world across two days. The panel of prominent industry leaders and world-leading scientists will share the latest case studies, innovative developments for novel therapeutic products and strategies for drug development.
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