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European Pharmaceutical Contractor

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Autumn 2010

 
   
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Marketplace & Business
The editor of EPC, Graham Hughes, gives a breakdown of this year’s annual DIA meeting in Washington DC.
 
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When describing the status of the outsourcing industry and clinical service CROs, the phrase ‘Nothing can happen in this country until somebody sells something’ is apt. Michael Martorelli of Fairmount Partners assesses the industry over recent years and identifies some future trends of business generation.
 
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A CRO-sponsor relationship is more than just commissioning a project and sitting back expectantly, explains industry advisor Anne Maria Ylisaari. Both parties need to communicate, be flexible, and work together to achieve a common objective.  
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Tim Dietlin of INC Research considers other options for sharing financial risks – such as spreading operational and compounds risks – when CROs reach the stage in a partnership where they must commit resources to the project.
 
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With the increasing trend of outsourcing to emerging markets, Antal K Hajos of Ecron Acunova GmbH highlights the first steps in the planning and setup of a programme, as well as for maintaining coordination and communication throughout the process, using India as an example.
 
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While physicians, pharmacists and trial investigators will usually understand the medical contents of a document, they may not be the best judges of translation quality, especially given the intricacies of certain languages. Carefully selecting and recruiting translation providers is crucial, explains Simon Andriesen at MediLingua.
 
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Legal & Regulatory
The clinical trial market in Poland has huge, untapped research potential that could not be exploited previously due to the high number of regulations. With proposed legislative changes on the horizon, Marta Gibala and Michael Sigmund at SSS International look into what this will mean for the region.
 
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Graeme Ladds at PharSafer Associates Ltd weighs up the risks and benefits of outsourcing safety to CROs and suggests that the sponsor’s relationship with the CRO must involve communication at all times. It also requires a degree of internal pharmacovigilance in order to comply with safety regulations – especially if the company intends to expand.
 
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Clinical Development
“Children are one third of our population and all of our future”; despite the relatively small market size, there are legal, regulatory and economic incentives for companies specialising in this area, points out Nilesh Nayak at Rubicon.  
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Annette Stemhagen and Gerald Faich of UBC compare various approaches to collecting much-needed periapproval data during late stage studies, which can help to identify areas of risk and eliminate them through better documentation and research.  
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Scott Dixon of Phase Forward explains why web-based ePRO is becoming the preferred solution to post-market pharmacovigilance, providing data quickly, efficiently and cost-effectively, which in turn can improve the safety profile of drugs and even shorten the duration of late phase studies.  
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In the current climate, the cost of a failed first-in-man study can be significant for companies; therefore, optimising the chance of success first time is becoming more desirable. Ian Siragher at Agenda 1 Analytical Services Ltd offers some approaches to achieving this goal.  
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DRUG DISCOVERY, DELIVERY & THERAPEUTICS
A centralised approach to electrocardiogram data collection can help to improve the quality of captured data, explains Amy Furlong at ERT. Furthermore, a recent study of investigative sites conducted by the Tufts Center for the Study of Drug Development (CSDD) showed that over half of respondents expect the use of these methods to increase over the next few years.
 
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Gerald McDougall of PricewaterhouseCoopers makes the case that collaboration is essential to the progression of personalised medicine, and stresses the importance of payers and consumers in the new ‘Big Pharma’ business model.
 
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Thomas Ng and Patrick Melvin at Premier Research Group Ltd explain the role of feasibility assessments in conducting oncology clinical research and how thorough planning from the onset will allow informed decisions to be made and will ultimately maximise the overall study outcome.
 
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Data Management & IT Solutions
Risk-based site monitoring, partial SDVs and eClinical technologies such as web-based randomisation, eTMF and ePRO, can yield significant time and cost savings for organisations, argue Stephen Young and Ashwin Mundra of Medidata.  
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Darlene Kalinowski at Bristol-Myers Squibb acknowledges the challenges today’s clinical trial sites face and explores the pros and cons of some of the key technological developments, such as EHR systems.  
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News and Press Releases

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