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| home > ict > Spring 2010 |
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 PUBLICATIONS |
International Clinical Trials |
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| Walter Janssens, Kristof Bonnarens and Greet Musch at the Federal Agency for Medicinal and Health Products, Belgium, outline the regulatory rules for exploratory clinical trials. |
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Mario Tanguay of Anapharm looks at new strategies for designing and conducting Phase I studies which can help to streamline the early clinical drug development process. |
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| Having already been recognised and applauded for their achievements to date,Vanessa Poustie gives us an insight into what else to expect from the NIHR Medicines for Children Research Network as they work towards improving child health. |
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| Planning for a clinical study is more than just determining the aim, as John Shillingford at Averion will tell you; in these times of financial crisis, the metrics – costs and timelines – of a study are just as crucial. |
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| Scientists are probably not always best known for their communication skills, concealing inadvertently the very thing they mean to communicate. Julia Forjanic Klapproth and Barry Drees of Trilogy Writing & Consulting GmbH examine the role of the medical writer as a strategic partner on the clinical team. |
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| Karen Politis Virk at Language Connections looks at the benefits of outsourcing clinical trial research to South Korea over other emerging markets, as well as the challenges faced by investigators. |
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| If you’re thinking of conducting clinical trials in the Middle East and North Africa, Maha Al-Farhan of ClinArt International provides accurate up-to-date information about the laws and regulations in the region. |
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| As the functional service provider (FSP) model increasingly replaces the traditional CRO paradigm for data management, Nelson Lee at the Society for Clinical Data Management reveals the elements needed for a successful FSP partnership. |
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| John F Tomera at WorldCare Clinical illustrates how adaptive clinical trials may be the future of R&D – citing adaptive designs, interim analysis and imaging CROs as tools for ensuring more effective portfolio management. |
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| Paula McHale at Perceptive Informatics explains why, despite the availability of electronic data capture technology, paper can be the best way to go on occasions. She provides guidelines for selecting a good hybrid tool that can manage both means of data collection. |
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| With the recent financial pressures on the pharmaceutical clinical development process, Ed Krasovec of STARLIMS Corporation explores the use of Laboratory Information Management Systems as a solution to the problem – improving efficiency and reducing costs. |
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| Intranasal drug delivery has always been a viable alternative to oral or subcutaneous routes for drugs with low bioavailability and, despite the challenges involved, recent developments have been eye-catching, explains Andrew Leary at Shandon Clinic. |
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News and Press Releases |
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Non-invasive SONOFLOW | Flow Sensors and SONOFLOW | C³ Software: The user-friendly smart sensoring package for application in laboratory 4.0, R&D, and single-use production environments
With the influence of digitization and increasing needs for process monitoring, laboratory, R&D, and single-use production environments are changing rapidly. Networked laboratory devices with smart functions, automation concepts, and efficient interface solutions have altered laboratory workflows and stand for the new era of Lab 4.0. Therefore, a rising tide of the continuous availability of data requires an easy data handling and secure data logging.
More info >> |
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White Papers |
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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.
More info >> |
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Industry Events |
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World Vaccine Congress Europe
18-21 October 2020, Barcelona, Spain
The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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