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| home > ict > Summer 2010 |
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 PUBLICATIONS |
International Clinical Trials |
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| John Lewis of the Association of Clinical Research Organizations assesses recent findings demonstrating the effects of culturally specific regulations on patient participation, and the hidden burden facing physicians. |
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| Past mistakes should be avoided through researching sources carefully and developing strong foundations for dialogue. Hugh Davies of the National Research Ethics Service presents an approach to utilise resources when reviewing the ‘facts’ more efficiently.
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| Incorporating the planning of integrated summaries from the beginning of the process of a product’s approval can avoid a lack of clarity when making key decisions; Michael Whitworth from Quanticate investigates. |
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| Pharma companies now spend up to 60 per cent of their R&D capital on clinical trials and make significant losses each day that there’s a setback. As patient participation is one of the principal factors that can lead to such delays, Benjamin Jackson of Quartesian recommends internet-based recruitment as a targeted way of finding willing patients. |
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| Kim Boericke at i3 Research and Bill Gwinn at i3 Pharma Informatics discuss the importance of protocol design, country and site selection, investigators’ experience and patient recruitment before the start of any study to ensure a speedy conclusion. |
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| James McRedmond of Java Clinical Research points out that the pharmacodynamic effects of a drug is what allows for better decision-making in the clinical development process, and draws attention to how one can improve the accuracy and quality of the data obtained. |
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Despite shrinking budgets the late phase research sector grew last year, seeing global outsourcing rise and post-market surveillance increase. David Selkirk of Omnicare Clinical Research asserts how late phase research can continue to provide benefits to the industry as a whole.
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| As Latin America becomes an increasingly popular destination for clinical trials – with the number of studies conducted in the region expected to increase by an average of 20 per cent each year – Fernanda C Durán and Valeria Francesconi at PharmaNet Development Group consider the potential benefits and challenges for companies considering this move. |
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| As well as embracing and adapting to new technologies, pharma companies need to remember that no solution is effective in isolation. Jim DeSanti of PharmaVigilant explains how EDC and EMR systems can work together to achieve more efficient results. |
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| How organised are you when it comes to creating internal documents with several inputs – who is doing what, when, and on which version of the file? Kris Sæther and Andreas Jordell at Xait suggest ways to ensure constructive collaboration. |
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| Christina Hughes and Kimberly Foulds at United BioSource Corporation explore ways of reducing variability in clinical data due to subjective endpoints, focusing on video surveillance and how this method can actually improve the overall quality of data accrued. |
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| It is estimated that 70 per cent of new chemical entities entering drug development programmes are unable to undergo sufficient gastrointestinal absorption to ensure efficacy. John McDermott of Quotient Bioresearch believes that early screening of prototype formulations is beneficial to avoid delays to the process. |
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| James Blakemore and Brennan Miles of Team Consulting Ltd discuss the importance of considering medical device function and design during the concept generation stage – pointing out that, in the end, the suitability of the overall product to the user is what will determine the level of the drug’s commercial success. |
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| With testing options changing constantly, and protocols becoming more complex, central labs have a pivotal role to play in the conduct of clinical trials. Elena Logan of ACM Global Central Lab considers how outsourcing will continue to affect lab testing. |
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| Reflecting on the evolution of the central laboratory, Thomasz Anyszek of LabConnect Europe and Synevo Central Laboratory, and Eric Hayashi and Frank D Morrow of LabConnect, LLC discuss the ongoing advantages and disadvantages of local and central frameworks. |
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| As the possibility of integrating emerging markets into clinical research supply chains increases, Alex Klim and Eddie Aston of DHL Supply Chain offer an insight into the potential obstacles that lie ahead. |
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News and Press Releases |
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PCI Pharma Services Announces Agreement to Acquire Sherpa Clinical Packaging
Philadelphia, USA – September 10, 2018 Leading global biopharmaceutical outsourcing services provider PCI Pharma Services (PCI) is pleased to announce the acquisition of San Diego-based Sherpa Clinical Packaging (Sherpa), which expands PCI’s U.S. operations to the West Coast. The acquisition of Sherpa, a provider of clinical trial supply services, further strengthens PCI’s position as a leader in outsourced clinical trial support services. The addition of Sherpa’s capabilities also enables PCI to better support customers from early phases of clinical development through to commercial launch.
More info >> |
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White Papers |
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Sourcing Commercial Drugs for Clinical Trials: US vs. EU Understanding the Differences
Myoderm
Sourcing commercial drugs for clinical trials is a dynamic process. There are many factors to consider: single source or regional sourcing, strategy, price, supply availability, lead times, and documentation are just a few. In the past, there were fewer clinical trials that required commercial drug sourcing, so demand was not as high. Today, the demand for commercial drugs in clinical trials has greatly increased and, as a result, inventory is tighter, orders are monitored more closely by manufacturers, and lead times have increased. This report highlights the key differences in sourcing from the US and EU.
More info >> |
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Industry Events |
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BIO-Europe 2018-24th Annual International Partnering Conference
5-7 November 2018, Bella Center Copenhagen, Denmark
The 24th annual BIO-Europe® event is the largest biotechnology partnering conference held in Europe. Over 4,000 global decision makers from biotechnology, pharma and finance annually attend BIO-Europe to identify new business opportunities and develop strategic relationships.
Business development executives and dealmakers consider BIO-Europe a must-attend event and an effective business strategy enabling them to meet and present to numerous potential partners. BIO-Europe features the industry’s most advanced web-based partnering system enabling delegates from all parts of the biotechnology value chain to quickly identify, engage and enter into strategic relationships that drive their business successfully forward.
More info >> |
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