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International Clinical Trials

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Autumn 2010
   
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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.

 

 
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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.  
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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.  
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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.  
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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.  
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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.  
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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.  
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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.  
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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.  
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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.  
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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.  
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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.  
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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.  
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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.  
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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.  
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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.  
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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.  
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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.

 
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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.  
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

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August, and November

News and Press Releases

Nemera announces a better drug deposition with RetroNose to enhance therapeutic efficacy of nasal treatments

After announcing a partnership with the Research Center for Respiratory Diseases (CEPR) of Inserm/University of Tours in April 2017, Nemera is happy to publish enhanced drug deposition results compared to classic nasal sprays with RetroNose.
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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

PDA Europe Annual Meeting 2019

24 June 2019, Hilton Amsterdam

Featuring updates from international regulatory agencies as well as industry, this promises to become another highlight in the 2019 event calendar and is a meeting not to be missed!
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