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European Pharmaceutical Contractor
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Well here I am. It will come as no surprise to many of you involved in clinical trials that I am waiting in customs in the middle of Central Europe, wondering quite how I got here. I have been here for several hours and am hoping to fly to London today so that I can reach my final destination intact and in an analysable state. What am I, you ask? In fact I am a blood sample from an HIV-positive patient. The patient in question is enrolled onto a Phase II clinical trial and I am enroute to a central laboratory where I will be examined to see whether the drugs my owner has been taking are having the effect the scientists think they ought to.
When the results are printed off and recorded in the case report form (CRF), no one ever really takes the time to consider my experience in all this. Do you have any idea of the tribulations I have been through in order to provide the scientists with data? No, I doubt very much whether you have. From the moment I am drawn from the patientÕs arm to the moment you see the results, I have been through a complete ordeal. This might sound overly dramatic today and I must admit, it is not always so bad, but I have the odds stacked against me. First of all, I was taken from an HIV-positive patient in a small village a few hours drive from Moscow in Russia, and am now travelling the long distance to London to be analysed.
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By Helen Springford, Director of Business Development, UK and North America, at IMFORM, and Sue Lee, Manager of BioPharm Systems, Research and Development at World Courier
With an honours degree in Nursing, Helen Springford worked in cardiac transplantation in both the UK and Australia before moving to clinical research in 1992. She worked as a Study Site Co-ordinator in the cardiovascular field and then as Manager of a London-based SMO, before moving onto project management within the CRO Pharmakopius (taken over by PRA) in 1997. Since then, Helen has worked in hepatology for GlaxoWellcome, but moved back to the CRO service sector as a Senior Project Manager with the CRO Pharm-Olam with whom she progressed to the position of Director of Global Business Development. In May 2004 she became Director of Business Development for UK and North America at IMFORM. Helen is a firm exponent of running clinical trials in emerging markets, with a specific focus on Central and Eastern Europe.
Sue Lee has a background in microbiology and has worked for World Courier for 15 years. As Manager of BioPharm Systems, Research and Development at World Courier in London, she oversees the logistics for multinational clinical trials controlled from the UK. SueÕs other responsibilities at World Courier include being a member of a global team working on the development of new and innovative systems for packaging, freezer facilities and training programmes, and providing consultation and technical expertise to shippers, sponsors, labs and World Courier working groups on training, shipping and dangerous goods. She is a qualified DSGA for road and rail and IATA-trained for shipping dangerous goods including radioactives. Sue is also a member of the Institute of Freight Professionals (Grad) and is approved by the CAA as a trainer for dangerous goods.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
More info >> |
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News and Press Releases |
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New PFA SonicLine® ultrasonic flowmeters
Flow measurement with ultrasound fast, precise, free from contamination The new PFA SonicLine® ultrasonic flowmeters assure precise measurement and control of chemical consumption and management of chemical stocks with high reliability. SonicLine® is also ideally suited for accurate batch and dosing processes with high reproducibility.
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