spacer
home > ict > Autumn 2009
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.
   
Text
PDF
bullet
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.  
view
bullet
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.  
view
download pdf

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.

 
view
download pdf
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.  
view
download pdf
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.  
view
download pdf
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.  
view
download pdf
bullet
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.  
view
download pdf
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  
view
download pdf
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.  
view
download pdf
bullet
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.  
view
download pdf
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.  
view
download pdf
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.  
view
download pdf
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.  
view
download pdf
bullet
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.  
view
download pdf
bullet
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.  
view
download pdf
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.  
view
download pdf

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.

 
view
download pdf
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.  
view
download pdf
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.  
view
download pdf
   
spacer


Published quarterly in
February, May,
August, and November

News and Press Releases

UK Tech Spinout Salient Bio Launches Fastest Ever Robotic COVID-19 PCR-Based Tests With A Gold Standard Accuracy Of Over 99%

Rapid test platform is up to three times faster than competitors for mass testing and is already being used by a range of businesses that require regular human contact in sectors including logistics, entertainment, sports, healthcare and education. Strategic aim is to provide affordable, effective and easy-to-access pre-emptive diagnostic solutions for a range of medical conditions that facilitate early intervention and improve overall health outcomes.
More info >>

White Papers

Mouse Models for Evaluation of Vaccines and Therapeutics Against Staphylococcal Infections

IBT Bioservices

Introduction Staphylococcus aureus (SA) is a ubiquitous, formidable Gram-positive pathogen associated with skin and soft tissue, as well as lifethreatening systemic infections. SA is a leading cause of hospital- and community-associated infections worldwide, affecting humans and animals. The wide range of pathologies reflects the diverse abilities of this microbe to escape the innate and adaptive immune response using virulence factors. Since its first emergence in the 1960s methicillin-resistant SA (MRSA) has become endemic in hospitals and healthcare settings worldwide. In the 1990s, community associated MRSA strains (CA-MRSA) emerged, and are spreading worldwide posing a major global challenge.
More info >>

Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement