spacer
home > ict > Autumn 2010
PUBLICATIONS

International Clinical Trials

ict
Autumn 2010
   
Text
PDF
bullet
REGULATORY

Complicated and rigorous, the safety management process can often become an ardous but necessary burden for trial coordinators to carry. Miriam Marotti at Prism Ideas shows how pharmacovigilance providers can lighten the load.

 

 
view
download pdf
Risk management has become a task for all levels of business operations since the publication of ICHQ9 Quality Risk Management.Andreas Grund of GCP Service International explains how to reassess approaches to risk, ultimately treating them as an opportunity to add value.  
view
download pdf
bullet
TRIAL MANAGEMENT
Paediatric clinical trials pose ethical, regulatory and practical issues,which have led to low interest from pharma companies. Philippa Smit-Marshall at PharmaNet explains how these hurdles can be overcome in sites around the world.  
view
download pdf
Cyril Clarke at ICON Development Solutions shows how the expensive, largely unsuccessful process of researching a new drug can be offset by a shift in the proof-of-concept stage, which aims to minimise the impact of failed Phase III trials.  
view
download pdf
The drug approval process in the EU is faster and more transparent – something which US firms would do well to take advantage of. Angus G Cameron at Pharmarama Inc discusses the details of sourcing EU-approved drugs for bioequivalence studies.  
view
download pdf
bullet
Regional trials
With its large population and highly developed economy, Japan should be a prime location for clinical trials.However, there are a number of obstacles holding the location back, explains Jeremy Buchman at BBK Worldwide.  
view
download pdf
Dana L Niedzielska and Mikhail Kandalov at PPD introduce Russia’s clinical research sector and the rapid progress that has been made in the country’s various regions over the last 15 years, and discuss how further development can be pursued.  
view
download pdf
In a continuation of the eastern European focus,David Passov at ClinStar delves into the financial benefits of choosing to conduct trials in the region, giving examples of how time, and therefore money, can be saved for both sponsor and CRO.  
view
download pdf
The third in the series, Oleg Mediannikov and Denis Pyak at Tetrial CRO focus on the Russia’s response to clinical trials for generic drugs, and point out the regulatory issues that must be overcome by CROs, while also charting the potential for development in the region.  
view
download pdf
Bindhya Cariappa of ClinTec International turns to India and the Gulf region to look at the high prevalence of diabetes in these locations, and how they offer a valuable opportunity for clinical researchers, in terms of both the variety and naivety of the population.  
view
download pdf
eCLINICAL, DATA MANAGEMENT & STATISTICAL ANALYSIS
Nick Halkitis, Liz Moench and Duncan Shaw at MediciGlobal reveal a host of options for online patient recruitment and point out that, despite rapid development in the digital world, clinical researchers in the real world are still playing catch-up.  
view
download pdf
Hard copy records are still firmly ingrained in today’s clinical trials administration systems, despite the clear advantages of electronic archiving has to offer. Dimitri Stamatiadis at Merck Serono highlights these benefits and assesses how change can come about.  
view
download pdf
Scott Dixon of Phase Forward Inc shows how web-based ePRO can improve the information provided by patient reported outcomes, offering a more accessible user experience as well as providing an element of control that appeals to patients.  
view
download pdf
bullet
THERAPEUTICS
Radiography is currently entrenched as the standard FDA-approved method of clinical assessment for rheumatoid arthritis. However,magnetic resonance imaging can be shown to be superior on many counts, as Harris A Ahmad at BioClinica, Inc illustrates.  
view
download pdf
The market for autoimmune disease therapies in the developed world is undergoing rapid growth and companies’ sales are increasing accordingly. However, James Wentworth at Datamonitor believes less developed economies may also harbour similar untapped potential.  
view
download pdf
bullet
Drug delivery & Therapeutics
Berwyn Clarke and Aino Telaranta-Keerie at Lab21 chart the progress of recent developments in cancer therapeutics; revealing successful avenues for molecular diagnostics in oncology and giving examples of molecules that have not lived up to their potential.  
view
download pdf
Chris Moriarty at Randox Pharma Services explains how a three-pronged offensive can often be the best solution when choosing a diagnostic partner, and provides a breakdown of what factors to consider in the selection process.  
view
download pdf
bullet
Labs & Logistics

Geraint Thomas at Laminar Medica explains how Class 6, Division 6.2 infectious biological substances can present a serious challenge for logistics managers, and offers insight into clinical trial packaging technologies that fulfil the regulation’s requirements.

 
view
download pdf
Editor Graham Hughes looks at The Professional Guinea Pig by Roberto Abadie, which charts the experiences of those who partake in clinical trials for a living.The book examines the patients’ views on the risks they assumed by participating on a regular basis.  
view
download pdf
   
spacer


Published quarterly in
February, May,
August, and November

News and Press Releases

Gelomics Partners With Rousselot Biomedical to Create the World’s First, Ready-to-Use 3D Cell Culture Kits Based on X-PURE® GelMA

Irving, United States, 16th November 2022 / Sciad Newswire / Darling Ingredients’ Health Brand, Rousselot, the global leader in collagen-based solutions, and Gelomics, the world-leading provider of fully integrated 3D cell, organoid and tissue culture technologies, have entered into a cobranding partnership. Rousselot Biomedical will supply Gelomics with its X-Pure GelMA (gelatin methacryloyl), a photo cross-linkable extracellular matrix, for use in Gelomics’ LunaGel™ 3D Tissue Culture System.
More info >>

White Papers

Industrial Security in the Pharmaceutical Sector

COPA-DATA

As an attractive target for cyber attacks, pharmaceutical companies need to understand cyber security, assess weak points and implement the appropriate security measures. This white paper describes some of the most effective industrial security tools pharmaceutical companies have at their disposal in the era of Industry 4.0.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement