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International Clinical Trials

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Summer 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
   
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Clinical Trial Management
Whether a study is global or regional, involves paediatrics or adults, or is lengthy or short, there are universal drivers that ensure patient recruitment and retention success. Liz Moench of MediciGlobalTM Inc explains what to consider and how to leverage these factors to your advantage  
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Alan Phillips of ICON Clinical Research investigates strategies for reducing patient numbers in clinical trials during the design phase  
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Simon Andriesen at MediLingua BV discusses the linguistic aspects of running multinational clinical trials and explores the unique solutions that are employed in the pharma sector  
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eCLINICAL
Leveraging the real value of clinical trials management systems means looking to a next-generation integration framework, suggest David Stein and Bill Byrom of ClinPhone  
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Bill Cochran of CRF Health outlines how electronic patient reported outcome data collected in clinical trials reduces the number of subjects per study, improves subject diary compliance, and ultimately shortens time to market  
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THERAPEUTICS
Nick Hughes of PA Consulting and Roger Edwards at Northeastern University, Boston, Massachusetts, take on the burden of applying next generational tools to the issue of diabetes and look at the ways to integrate these innovative new approaches  
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The instruments for safety and efficacy assessments in psychiatry studies cover different scales; Natalia Ezhkova of Synergy Research Group examines how the results of placebo-controlled studies can be improved in clinical trials  
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data management & statistical analysis
Is CEE still a paradise for clinical research? Karel Cerny, Xavier Ducarme, Monika Kowalik and Dan Militaru at SGS Life Science Services focus the spotlight on the Czech Republic, Poland and Romania  
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Labs & Logistics
An experienced central laboratory is an excellent option when considering outsourcing. Get it right, explains Anne Marie Gaulin of CIRION Clinical Trial Services, and they can become an extension of the in-house scientific team, with core competencies in assay development and with the added capabilities of providing support throughout the clinical development process.  
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Effectively managing the clinical trial supply chain is no easy task, but the rewards for those with a sound strategy in place can be impressive; Sivakumar Rajagopalan and Rebecca Drinkwater of BearingPoint investigate  
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News and Press Releases

Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older

Pfizer Inc. and BioNTech SE today announced that the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. COMIRNATY is the first COVID-19 vaccine to be granted approval by the FDA.
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White Papers

Risk-Based Inspection Readiness: Reducing Headaches with Advanced Preparation

The Avoca Group

So often, inspections are a major source of stress in the clinical trial environment. This is especially true when processes involved in preparing for an inspection are reactive. But, it doesn’t have to be that way. Using industry-leading practices and resources enables a proactive approach to mitigate—or even eliminate—the pain points associated with preparing for inspections.
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