spacer
home > ict > Autumn 2008
PUBLICATIONS

International Clinical Trials

ict
Autumn 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
Regulatory & Business Practice
Tim Worden of Taylor Wessing LLP discusses the MHRA’s investigation into GSK’s reporting of adverse events in Seroxat paediatric clinical trials  
view
download pdf
Sarah Powell at Liquent examines the results of a 2008 regulatory affairs trends survey of the pharmaceutical industry  
view
download pdf
The latest European Court ruling fails to resolve parallel trade uncertainty, reports Edward Miller of Reed Smith  
view
download pdf
bullet
Clinical Trial Management
Nicola Murgatroyd of Phlexglobal Ltd explains how finding and keeping people with the right skills, from secretaries to a highly experienced clinical research professionals, can energise a company  
view
download pdf
Angus Cameron at Pharmarama gives his advice on deploying comparator drugs in China for global clinical trials  
view
download pdf
Steve Toon of Simcyp Limited argues that the pharmaceutical industry must tap into the real value of modelling and simulation in drug ADME  
view
download pdf
Colin Garner and Graham Lappin at Xceleron explore safety testing of drug metabolites and look to gain a better understanding of human drug metabolism at an earlier stage  
view
download pdf
bullet
eCLINICAL
The convergence of electronic health records and clinical research is changing the way the pharmaceutical industry operates. Jacob Helton, Landen Bain and Rebecca Daniels Kush of the Clinical Data Interchange Standards Consortium (CDISC) and Linda King of Eli Lilly and Company investigate an evolving landscape  
view
download pdf
Urban Fröderberg of Anoto AB examines how digital pen and paper technology, as a relative newcomer among data capture tools, can help address some of the hurdles encountered by CROs  
view
download pdf
Robin Longdin of LCG Bioscience and Nick Townsend of LabWare Europe discuss the introduction of a new-generation laboratory information management system (LIMS) into a busy Phase I clinical trials facility  
view
download pdf
Portable software helps monitors manage site visits, validate protocol compliance, and assess the integrity of trial data, insists John Humphreys of Perceptive Informatics, a PAREXEL International company  
view
download pdf
bullet
THERAPEUTICS
Mike Wyllie of Plethora Solutions charts the trends in urological drug development – an untapped market where medical need is at present poorly met  
view
download pdf
bullet
Labs & Logistics
Don Riach at Marken reviews the challenges of transporting diagnostic blood samples back to central laboratories in a timely manner  
view
download pdf
Jeff Clark of BioStorage Technologies Inc reveals how in-home clinical trial service mitigates risk with a strategic, holistic approach to cold chain management  
view
download pdf
Natasha Molnár of SCA Cool Logistics asks whether it is possible to find a packaging solution which ticks all the right temperature-controlled boxes  
view
download pdf
   
spacer


Published quarterly in
February, May,
August, and November

News and Press Releases

SHIONOGI’S NOVEL ANTIBIOTIC, FETCROJA® (CEFIDEROCOL), HAS BEEN SELECTED BY UK’S NICE / NHSE&I AS PART OF AN ANTIMICROBIAL SUBSCRIPTION STYLE REIMBURSEMENT MODEL

The National Institute for Clinical and Health Excellence (NICE) and the National Health Service England and Improvement (NHSE&I) have recognised the potential of Shionogi’s innovative antibiotic, cefiderocol, and selected it for inclusion in this pilot reimbursement model which ‘de-links’ payment from volume of use Shionogi recognises the UK’s leadership role in introducing this first fully ‘delinked’ pilot reimbursement model, which is an important step in making the market for novel antibiotics more predictable and sustainable; we strongly believe in the introduction of further suitable pull incentives in order to help stimulate the antimicrobial development pipeline Fetcroja® (cefiderocol) is indicated for the treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options1 Antimicrobial resistance (AMR) is a major health burden which results in over 700,000 deaths globally2 and 5,000 deaths per year in the UK3 from an infection with multidrug-resistant bacteria and this is predicted to kill 10 million people every year globally by 2050, unless action is taken2
More info >>

White Papers

Clinical Trial Disclosure Management: Build vs. Buy

TrialScope

Because software development is our core competency, TrialScope continues to make a significant investment in our technology. We employ agile methodologies to ensure that we can maintain a continuing level of responsiveness as disclosure requirements evolve across registries and regions.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement