samedan logo
 
 
spacer
home > ict > Spring 2008
PUBLICATIONS

International Clinical Trials

ict
Spring 2008
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
Clinical Trial Management
Raising the Bar for patient recruitment methods has included the use of a comprehensive in-house database covering a wide range of countries and therapeutic indications.This method, which is increasingly being used by CROs, involves a more scientific and targeted approach and should become a new standard for best practice within the industry, argues Alan Morgan of ICON Clinical Research  
view
download pdf
Challenging current paradigms associated with automated cognitive testing within clinical trials,Mark Cusack of CDR looks at ways to employ the appropriate systems that can provide the industry with greater operational efficiencies, scientific insight, and Brain Power  
view
download pdf
The creation of data monitoring committees is almost a routine practice in randomised control trials that are performed specifically to register a human medicinal product. In Credible Risk Management, Gurdyal Kalsi of MDS Pharma Services assesses the value of data monitoring committees from the perspective of a CRO  
view
download pdf
bullet
MICRODOSING
David Edwards of Capsugel assesses the teething problems faced by those trying to introduce new drugs into the marketplace. The restriction of resources in early stage drug development, such as available drug quantities, testing personnel, equipment, funding and, perhaps most crucially, time, are all considered in Beyond Fast Filling  
view
download pdf
bullet
MEDICAL IMAGING AND QT STUDIES
The success of a trial, and ultimately clean study data, is determined during the initial stages of the process. In Sound Starts, Frank Dunn and Jeffery Bowden of Biomedical Systems discuss the question of logistics, and assess the safety and efficacy of a particular drug or medical device used in clinical trials  
view
download pdf
In Expect the Unexpected, Oliver Bohnsack and Manuela Lesch of Perceptive Informatics assert that in order to advance the procedure of clinical trials, dramatic improvements within medical imaging technologies are vital, as is the need to regularly review those directly involved in conducting the trials in order to provide consistent results  
view
download pdf
bullet
GLOBAL OUTSOURCING & REGULATORY COMPLIANCE
As the outsourcing scene opens up to emerging markets, pharmaceutical companies must make decisions about which of the key regions to focus on when it comes to clinical trials. Jerry Boxall of ACM-Pivotal Europe gets on the trail in Materialising Markets  
view
download pdf
Jaime Caro of United BioSource Corporation considers how Surmounting the Hurdles of New German Regulations will mean that companies can no longer leave the economics to Phase IV – early preparation is called for  
view
download pdf
In The Global Player, Nilesh Vite and Arulsingh Jayaraman of Lambda Therapeutic Research assess India’s role as a burgeoning player for the outsourcing of clinical trials,placing the focus on efficient subject recruitment and effective cost management  
view
download pdf
bullet
THERAPEUTICS
In The Fibrotic Process, William Rosenberg of University College London assesses the worldwide impact of chronic viral hepatitis, alcoholic liver disease and non-alcoholic fatty liver disease on the pharmaceutical and biotechnology industries in terms of their earning potential for new therapeutic interventions and diagnostic tests  
view
download pdf
As sleep medicine makes its mark on drug development in the pharmaceutical industry, Martin King of LCG Bioscience outlines some of the most common sleep disorders and their implications, and explains the techniques available for practitioners undertaking specialist sleep trials, in More Than a Sleeping Partner  
view
download pdf
bullet
Labs & Logistics
Global consolidation within the pharmaceutical industry is becoming increasingly necessary in the current economic climate. In Solid Supply, Chris Tierney at DHL Excel Supply Chain examines this shift alongside the need for cost reduction and service enhancement in what is a highly competitive industry  
view
download pdf
   
spacer
Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

Nemera organized an expert review on the present and future of inhalation products

“Connectivity in every new inhalation device?” This topic was one of those discussed with different inhalation experts - Manfred Keller, Pascal Cavaillon and Henry Chrystyn – during a round table organized by Nemera in Paris to review the advantages and limitations of inhalation devices.
More info >>

White Papers

Pharmacovigilance and Risk Management Information in Centralised Applications in the EU

United BioSource Corporation (UBC)

Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
More info >>

Industry Events

Clinical Trial Supply Europe 2019

13-14 March 2019, Milan, Italy

Following on from our largest and most engaging meeting to date, Clinical Trial Supply Europe will be returning to Milan for its 20th year in 2019! The 19th annual edition welcomed pharmaceutical companies across Europe who got together to share knowledge and issues regarding clinical trial supplies, both with regards to operational and technological challenges. Over the two days, delegates discussed issues which affected their business in our dedicated operational and technological streams.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement