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European Pharmaceutical Contractor

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Autumn 2007
At the cutting edge of the latest industry developments, Samedan is adept at keeping the information you need at your fingertips. EPC 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 the current issue of EPC
   
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Marketplace & Business
With outsourcing in the pharmaceutical and biotechnological industry growing at an annual rate of 14-15 per cent, Leslie Patmore and Peter Gaskin at Aptuit Consulting recognise that a client’s requirements differ depending upon their size.They offer their advice for big and small companies alike, in Outsourcing Strategies: from David to Goliath  
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Oriana Zerbini at CROM Srl talks to EPC about her proactive vision of management, urging CROs to take a rational and structured response to market demands and opportunities in order to acheive  
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Following the first part of her article in EPC Summer, Anick Duchesne at Debiovision Inc continues to investigate the optimisation of field clinical research monitors and examines the benefits of a non-traditional role, in Maximise Your Monitor: Part II  
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Brian Cass at Huntingdon Life Sciences discusses the shift that has taken place within the non-clinical contract research industry in The Evolving Nature of CRO-Customer Relationships  
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Back to Translation sees Simon Andriesen of MediLingua BV review the complexities of observing the EU regulations governing the availability of multi-lingual patient information leaflets and user instructions  
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As clinical trials become increasingly global Jessica Eker at TransPerfect Translations Ltd looks at the key steps for successful linguistic validation, in Breaking the Language Barrier  
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Legal & Regulatory
Ruediger Haecker and Paolo Marinelli at RCC Ltd recognise the importance of the first administration of a new investigational medicinal product in humans. First-in-Man focuses on the interface between non-clinical and early clinical development  
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In Prescribed Promotion, Sarah Powell of Liquent investigates the strategy adopted by the US regarding prescription drug advertising and promotion compliance  
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In order to satisfy regulatory compliance and deliver products to market faster than ever before, many life science organisations are now looking to integrate key building management and process control functions. Walfried Laibacher at Honeywell Building Solutions observes that integrating intelligent building management and process control solutions delivers a measurable return on investment, in Strength in Numbers  
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Clinical Development
Whilst EDC has delivered on its promise of much-improved data collection, critics note that the process has had little to no impact on cost reduction in other areas of the clinical development process. In light of other current solutions, Bruce D Schatzman at Advanced Clinical Software, Inc asks Will the Impact of CTMS Dwarf EDC?  
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As markets open up in previously unexplored areas, there has been a natural process of extending businesses into the newly emerged Eastern European territories – this is especially true of the pharmaceutical industry. Ralle Palaveev at Premier Research heralds Central and Eastern Europe as the New Kids on the Bloc  
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Today, pharmacovigilance is a complex and demanding field due to ongoing developments in areas such as data-mining, Eudravigilance and EDI gateways. Joseph Anderson at Waife & Associates Inc lends his advice, outlining Ten of the Best methods for responding to challenges faced by PV professionals  
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The last few years have seen pharmaceutical companies faced with obstacles ranging from pressures on profit margins and an absence of blockbuster molecules, to spiralling R&D costs, pricing pressures and higher overheads, leading to a spate of outsourcing deals within the sector. Martyn Hart of the NOA assesses the benefits of making A Passage to India  
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When it comes to IVRS, identifying and planning for potential problems ensures that, if the unexpected happens the resolution is quick and efficient, system users have a seamless experience, and any downtime is minimised. Samuel Bryant at Averion International Corp reflects on the importance of IVRS Contingency Planning  
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Clinical Laboratories & Logistics
As the global market expands to include emerging regions, the pharmaceutical industry is rapidly realigning its focus from the traditional regions of North America, Europe and Japan, and exploring the opportunities of expansion into the new markets available today. Jerry Boxall of ACM-Pivotal Europe, and member of the Institute of Clinical Research, stacks up the factors that are Pushing Boundaries  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
In Vital Vaccines, Ian Sellick at Pall Life Sciences provides a view of the conjugate vaccine market, exploring the mechanisms of action and market factors affecting vaccines, whilst highlighting new manufacturing techniques that speed up production  
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There is no denying the pivotal role of biomarkers in the development of pharmaceuticals, especially now that they’ve been identified by the US FDA as one of the cornerstones of innovation in drug development, in the 2004 Critical Path White Paper. Malle Jurima-Romet, Lena King and J Fred Pritchard from MDS Pharma Services advise us to join the race for success, in On Your Marks  
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In Teaching Old Drugs New Tricks, Catherine Brady, Alan Boyd, John Gordon and Nicholas Barnes of Celentyx highlight the benefits of drug reprofiling as a strategy for development, claiming that it delivers drug champions at a fraction of the cost, with the added benefit for patients that it is less likely to cause side-effects  
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Data Management & IT Solutions
In The Paperless Trial – Past, Present and Future, Jules Mitchel and Andrew Moncrieffe at Target Health Inc, Imogene Grimes, Vadim Tantsyura and Douglas Nadler at Regeneron Pharmaceuticals, Linda Harnevo at Global Medical Networks Israel Ltd, and Yossef Bahagon at Clalit Health Services, Hebrew University Hadassah Medical School, assess the impact of EDC and EHR on clinical data management  
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Many recognise that the integration of clinical systems drives efficiency and improves relationships, posing the questions – could this be improved, and what processes and information technology could facilitate the improvement? Marcus Thornton at Clinical Force examines The Payment Process with CTMS/EDC Integration  
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With the burgeoning number of e-options – from web-based and IVRS to handheld devices, such as PDAs – it will become increasingly important for decision-makers to make the best strategic decisions about whether, when and how to use various technologies. Nancy Kline Leidy and Makiko Meguro at United BioSource Corporation recommend Strategic Planning with ePROs  
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From the unexpected speed of wholesale GP compliance, with primary care trusts prescribing guidelines, to practice-based commissioning, GP practices have changed fundamentally across the NHS over the past 18 months. Gareth Thomas of Cegedim Dendrite considers novel approaches to sales and marketing, in a Prescription to Change  
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News and Press Releases

PCI Pharma Services Announces Acquisition of Millmount Healthcare

Philadelphia, PA – October 2, 2017 – Leading pharmaceutical outsourcing services provider PCI Pharma Services (PCI) has announced the acquisition of pharmaceutical and healthcare contract packaging services provider Millmount Healthcare, located near Dublin, Ireland.
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White Papers

PROTEIN:PROTEIN INTERACTION ANALYSIS

IBA GmbH

Groth et al., 2007 and Jasencakova et al., 2010 Protein:protein-interactions (PPI) govern almost all important processes in living organisms. Thus, their rapid and accurate determination and investigation is a major challenge in life sciences. The extremely efficient and fast One-STrEP (Twin-Strep) system is suitable for the isolation of functional protein complexes and subsequent mass spectrometry analysis leads to the identification of protein complex components (Junttila et al., 2005) as it is shown in the following studies.
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Industry Events

Clinical Trial Supply Forum 2018

22-24 January 2018, London, UK

In the constantly changing environment of Clinical Trial Supply, cost efficiency, end to end visibility, logistics and managing complex pipelines are STILL crucial elements that need addressing!
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