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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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Protagen Protein Services (PPS) reaches new level in characterizing HCP protein impurities
In response to current regulatory guidance a Mass Spectrometry (MS)
based Host Cell Protein (HCP) detection approach with faster, more
accurate and wider-ranging detection is essential. In order to meet the
newly prevailing demands Protagen Protein Services (PPS) recently
invested in more far-reaching MS capabilities: The new high-performing
mass spectrometer ThermoFisher Q Exactive™ HF-X started operational
service last month and brings PPS to the next level of reproducible,
accurate and sensitive analyses of majorly complex samples for different
aspects of translational research and biopharma applications.
More info >> |
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White Papers |
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Cleaning Validation: What do you need to consider to ensure a successful outcome?
RSSL
Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination.
The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support.
The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues.
So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
More info >> |
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Industry Events |
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10th Annual Summit for Clinical Ops Executives
18-21 February 2019, Hyatt Regency Orlando, Florida
Celebrating its 10th successful year, SCOPE Summit 2019 takes place
February 18-21 in Orlando, FL. Over the course of four stimulating days of
in-depth discussions in 19 different conferences, 3 plenary keynote sessions,
and the ever-popular interactive breakout discussions, the programming focuses
on advances and innovative solutions in all aspects of clinical trial planning,
management and operations, including...
More info >> |
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