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International Clinical Trials

ict
Winter 2006
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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In her Editor’s Letter, Pamela Barnacal peruses the latest offerings in the closing issue of 2006

 
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Regulatory & Business Practice
In the light of a recent, extensive review of the PASS guidelines, Martin Knight of Covance Late Stage Development Services examines the proposed changes and clarifications that must be considered when designing a pharmacovigilance programme, in A PASS Through the Drug Safety Range  
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The media storm surrounding the testing of monoclonal antibody TGN1412, and its subsequent effects on six volunteers, appears to have caused untold damage for clinical trial recruiters. In Trials and Tabloid Headlines, Alison Dennis of Reed Smith reviews the regulatory changes needed to protect patients - and in turn rebuild public confidence - following the traumatic turn of events at Northwick Park earlier this year  
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Clinical Trial Management
Why is the implementation of rigorous cognition assessments in clinical trials so important? In Know Your Trials, Mark Ware and Jennifer Lewis of Cognitive Drug Research explore the progression of cognitive research in drug development to the present day and beyond, reiterating the importance of using the best instruments available  
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The corporate strategy for recruitment is coming of age. With commentators calling for the introduction of a clear vision for clinical studies, David J Cocker of Goldwood assesses the impact of current environmental factors on the core challenge of recruiting volunteers, in Recruitment on Trial  
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As the mass of data accrued through patient safety assessments swells wildly, establishing a programme for the 21st century is paramount. In A Lab with a View, Alan Craig of ACM-Pivotal Laboratories puts the case for the professional clinical laboratory to strengthen the systems, test selection and analyses of clinical studies  
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Global Outsourcing
The prospect of tightening budgets and limited resources have forced pharmaceutical companies to re-evaluate their stance on outsourcing. Never has the time for collaboration between vendors and sponsors been so productive, nor so crucial, reports i3 Statprobe's Gregg Dearhammer as he unravels In and Outsourcing: Pharma's Evolutionary Side  
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Eastern Europe is now the second highest patient recruiting region in the world for industry-sponsored clinical trials. Richard Leach of RCT Global, LLC, investigates a compelling story of rapid growth, in A Home for Trials: the Bloc Reborn  
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eCLINICAL
Reducing the data entry backlog that typically follows paper diary studies may sound like a feat worthy of a magician, but the time to final analysis can indeed be shortened, asserts Symfo Inc's Judy Woods, as she begins the process of Demystifying e-Diaries  
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Rarely seen in clinical trials, IT governance frameworks like the Common Objectives for Information and related Technology (COBITTM), provide a much-needed end-to-end perspective; Dr Carsten Heil of Viasys Healthcare GmbH watches CDM on the Move  
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In SDTM and the Clinical Information Life Cycle, David Evans of Octagon Research Solutions Inc examines the FDA's preferred language for clinical information - vital to success in the collection, processing and submission of clinical research information  
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Clinical Trial Supply & Packaging
What are the objectives of EC guidelines such as Good Distribution Practice? In Ship-Shape Trials, the MHRA's John Taylor suggests how to avoid hazards when handling goods and ensure the shipping of clinical trial materials enjoys a smooth passage  
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No Transit, No Trial - this is the straightforward message from Eric Raemdonck of IATA, who delivers details on a Perishable Cargo Manual produced to promote prompt, stress-free transportation for clinical studies  
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Pharmaceutical products are being launched in an increasingly crowded market to ever more sophisticated consumers. Impressed by blister pack wallets, which offer patients a variety of applications, Raupack's Alan Holmes asks, What's In Your Wallet?  
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PREVIEW
Feel in the dark when it comes to clinical data management? Put a date in your diary for March 2007 and get to grips with integration across the clinical trial continuum, as DIA CDM Meeting Celebrates its 22nd Year  
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

MedPharm accelerates strategy to broaden service offering into commercial manufacturing

MedPharm Ltd, a leading contract provider of topical and transdermal product design and development services, has announced two new appointments to its Board to support plans to grow its commercial manufacturing services.
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White Papers

Transforming Temperature Data Management Practices to Reduce Labor Costs and Improve Visibility and Control

Berlinger & Co AG

There are a number of temperature monitoring database options available to the biopharma supply chain professional and choosing the right one can significantly improve workflow which will reduce administrative time. This article will provide insight into practices for improving common processes through enhanced database functionality in the areas of managing data loggers by expiry date, storing and retrieving calibration certificates and acknowledging/documenting common temperature excursion events. Additionally, it describes the unique features and benefits of the Berlinger Smartview® data management system. Smartview® is a “Software as a Service” (SaaS) platform designed to efficiently and accurately manage both workflow and data in a regulatory compliant manner (21 CRF Part 11 & Annex 11). This comprehensive temperature data management system ensures reliability, accuracy, security, accessibility, and visibility to supply chain professionals, enhancing Good Distribution Practices (GDP) of temperature sensitive shipments.
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Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>

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