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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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RoslinCT to Participate in the Northern Alliance Advanced Therapies Treatment Centre
RoslinCT, a UK-based cell and gene therapy contract manufacturing
organisation, is delighted to be part of the Northern Alliance Advanced
Therapies Treatment Centre (NAATTC) consortium. As an industry partner
within the consortium, RoslinCT will provide advice on the development,
manufacture and clinical supply of cell, gene and tissue engineered
therapies.
More info >> |
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White Papers |
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High Containment FIBCs Offer a Safe and Cost Effective Alternative to their Rigid Counterparts
ILC Dover
As the need for powder containment and manufacturing in accordance with cGMP standards has grown over the years, companies have sought new alternatives to rigid IBCs. Recently high containment Flexible Intermediate Bulk Containers (FIBCs) have emerged which offer an alternative that provides both powder containment and the benefits of shipping with flexibles.
More info >> |
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Industry Events |
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Nordic Life Science Days 2018
10-12 September 2018, Stockholm Waterfront Conference Center, Sweden
The Nordic way of doing life science business
NLSDays offers networking
and knowledge for anyone interested in the Nordic life science,
biotechnologies, pharmaceuticals, medical devices and e-health business. We
offer plenty of opportunities to connect.
More info >> |
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