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PUBLICATIONS

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-naïve 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

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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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

CPhI & P-MEC India 2018

12-14 December 2018, India Expo Mart, New Delhi, India

CPhI & P-MEC India (December 12-14, 2018) – organised by UBM (part of Informa PLC) – announces that the 12th edition of Asia’s largest Pharma exhibition is moving to the India Expo Mart, New Delhi. The new venue will see the exhibition now hosted in a single venue, bringing it closer to the Indian regulatory and legislative capital. New Delhi is also the country’s main international transport hub and will encourage an increased international attendance. In total, more than 50,000 people from 122 countries are expected, along with nearly 1,500 exhibitors.
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