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| home > ict > Summer 2008 |
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 PUBLICATIONS |
International Clinical Trials |
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| 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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| 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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| 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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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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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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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 |
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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.
More info >> |
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White Papers |
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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.
More info >> |
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