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International Clinical Trials

ict
Autumn 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
Setting up a global registry allows manufacturers to see how their products are being used in each country, and can aid risk assessment and minimisation. Kim Maguire and Bruce R Smith of United BioSource Corporation highlight design factors that should be taken into account and suggest strategy combinations.  
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Trial Management & Outsourcing
Keitia Brooks of PAREXEL International, Inc and Jeanelle Pierre of TTC, llc demonstrate how a CRO can focus on managing clinical grants in order to reduce operating costs and provide the best possible service, thus securing an edge in an increasingly competitive market place.  
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The enrolment of patients in a clinical trial is invariably expensive, challenging and time-consuiming. David Haddick of KDH systems, Inc presents a new screening method that could benefit principal investigators, physicians and patients alike.

 
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The outsourcing of medical equipment for clinical trials is a subject that is not always given the attention it deserves. David Maughan of Medical Equipment Supplies and Management Ltd outlines some key considerations which will ensure that the process runs smoothly.  
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Harry Wallace at RCM&D discusses the complex but critically important subject of clinical trials liability insurance, looking at the issues of limits and loss sharing, and the specificities of insurance for long-term and international trials.  
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The days when the pharmaceutical industry could rely on a steady stream of patent protect income are gone, but, as Julia Forjanic Klapproth of Trilogy Writing & Consulting GmbH argues, pharma companies can keep their operations viable by minimising the time and cost of clinical development.  
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Regional trials
Lower costs and large numbers of treatment-naďve patients are two of the main reasons for the recent explosion of clinical trials in south-east Asia, but there are fundamental language and cultural considerations to be taken into account when investing in the region, as Garry Muddyman of Conversis explains.  
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Though small in size and distant from the traditional centres of clinical research, New Zealand has the skills and experience to accommodate top quality, speedy and cost-effective clinical trials, say Christine Weston of Infinity Consulting Ltd and Shaun Holt of Clinicanz  
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Vitor Harada of ICON examines differences in international legal practice which, if not properly understood, can lead to major setbacks when conducting clinical trials abroad. Focusing on Latin America, he outlines some of the most common legal obstacles.  
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data management & statistical analysis
Technology is at its most efficient when it is unobtrusive, fading into the background of daily life. Graham Wylie of the Medical Research Network examines the developments within EDC technology, arguing that devices such as optical character recognition pens have made data capture easier, faster and more accurate.  
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Reducing security risks is crucial when transferring information. John Redfern of Inovis, EMEA, looks at the history of managed file transfer solutions and how companies can guarantee that the safe delivery of their files has not been compromised.  
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Many clinical trial companies still use a combination of older laboratory information software, but Joe Tehan of STARLIMS Corporation believes that employing a web-based unified laboratory informatics platform will reduce costs and improve harmonisation, meeting the demands of today's complex trials.  
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Adaptive design methodology is taking off with great success, proving that involving statisticians from the start of the clinical development process can reduce the risk of pitfalls, as Jeff Davidson of Octagon Research Solutions, Inc explains.  
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Drug delivery & Therapeutics
Paul LJ Tan, Kathleen Durbin and Robert Elliott of Living Cell Technologies Limited discuss the development of encapsulated porcine islets without immunesupression for the treatment of insulin-dependent diabetes.  
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Labs & Logistics
Using a laboratory capable of combining R&D expertise with central lab experience can be a crucial asset, and optimise product development. Fraser R Day of CIRION Clinical Trial Services suggests steps towards finding the right provider.  
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Digital imaging of pathology slides can provide pictures of the cellular levels of a disease. Frank Dunn at Biomedical Systems reveals how this can decrease the variability of results and improve the final data of a clinical trial.  
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Shipping clinical trial samples to emerging markets can present new regulatory and logistical challenges, but Jeff Clark of BioStorage Technologies illustrates the links that can be reinforced and hazards to look out for.

 
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Demonstrating green credentials is becoming an important target as companies try to minimise the environmental consequences of clinical trials. Geraint Thomas at Laminar Medica explains how to develop a maximum efficiency solution that produces minimal waste.  
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David Allen of ADAllen Pharma Limited looks at factors that must be taken into account during the process of procuring a comparator, and points out that careful planning from the early stages is necessary to avoid delays.  
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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

POP TEST ADDRESSES THE PROBLEM OF UNRELIABLE DATA FROM CONTINUOUS GLUCOSE MONITORS

A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6 Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
More info >>

White Papers

Clinical Research in Spain

BioClever

This whitepaper is on clinical research in Spain, giving a general outline of the main characteristics of research in this country and an overview of the applicable regulations, along with the reasons why Spain is a good place to do research.
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Industry Events

ChinaBio Partnering Forum 2018

25-26 April 2018, Kempinski Hotel Suzhou, Jiangsu, China

Access a world of opportunities through life science partnering in China. ChinaBio® Partnering Forum is the premier life science partnering event in China. The conference will be held April 25–26 in Suzhou, attracting biotech and pharma leaders from around the world along with hundreds of China-based developers of novel technologies for two days of productive partnering.
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