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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-na´ve 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

BioIVT Acquires Optivia Biotechnology, Adding Transporter Assay Products and Services to its ADME-Tox Portfolio

BioIVT, a leading provider of research models and services for drug development, today announced that it has acquired Santa Clara, CA-based Optivia Biotechnology and its comprehensive portfolio of transporter assays, multi-transporter models, transporter systems biology, and molecular transport research solutions.
More info >>

White Papers

Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services

DrugDev

With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
More info >>

Industry Events

10th Annual NGS & Clinical Diagnostics Congress

8-9 November 2018, London, UK

Oxford Global is proud to present its 10thAnnual NGS & Clinical Diagnostics Congress taking place on 8-9 November 2018 in London.  Part of the Genomics & Synthetic Biology Series UK, the congress will bring together over 600 end users representing internationally renowned research & academic institutions, clinical research institutions, healthcare organisations as well as leading pharmaceutical and biotech companies.
More info >>

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