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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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Pharmaceutical Manufacturing and Packaging Congress

Pharmaceutical Manufacturing & Packaging Congress (PHARMAP 2022) covers the current state of the pharmaceutical manufacturing and packaging industry. The Congress gathers pharmaceutical companies, CMOs and CDMOs, governmental bodies together with pharmaceutical equipment providers and service companies. It takes place on June, 20-21, 2022 in Berlin, Germany.
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Orthogonal Approaches for the Analysis of Protein Sequence

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One of the most important classes of biopharmaceuticals is monoclonal antibodies. They are expressed from living cells, and are consequently subject to complex biochemical pathways. Not all of these routes are fully understood, and many are sensitive to the subtlest of environmental changes. Changes such as these can affect the final biopharmaceutical sequence, structure and post-translational modifications, not to mention any changes that may occur during further purification. This often means that the final product from one batch may be different from the last in another batch. Each batch is a complicated mix of similar molecules, and analysis of the degree of batch-to-batch variation is therefore very important to the establishment of the drug's safety for medicinal use and patient administration.
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