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| home > epc > summer 2004 > no better time than the present: electronic data capture comes of age |
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 PUBLICATIONS |
European Pharmaceutical Contractor
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There is no starker picture of the challenge faced by pharmaceutical and biotech companies than to look at the way R&D expenditure continues to climb by over 10 per cent a year, despite the number of approved new treatments falling. Forced by revenue pressures to seek simultaneous multi-country approval and by regulatory authorities to include more patients and treatments in trials, sponsors are challenged to increase clinical trial productivity - the fastest growing component of R&D expense.
Over the last decade, sponsors have wrung efficiencies out of the clinical trial process by applying technology and streamlining processes. They have implemented clinical data management systems (CDMS) with sophisticated coding and query management capabilities and supplemented commercial systems with in-house applications. Through training and development of standard operating procedures, they have fine-tuned their clinical processes for collection, cleaning, analysis and submission of clinical data to the point where there is little opportunity to extract further improvements.
Pharmaceutical and biotech companies now find themselves in the situation traditional manufacturing companies found themselves in a decade ago. When manufacturers hit a wall and needed to apply new technology to boost productivity in the face of increasing volumes of data, they turned to enterprise resource planning (ERP) applications. Further improvements in clinical trial productivity require the adoption of a new generation of technology. Clinical trial sponsors are now turning to electronic data capture (EDC) applications to boost clinical trial productivity while simultaneously increasing data quality.
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By Steve Powell, Vice President and General Manager, International Operations at Phase Forward
Steve Powell is Vice President and General Manager of Phase Forward, a provider of data management solutions for clinical trials and drug safety. He has overseen the establishment of a European base in the UK, focusing on all commercial services and support capabilities. Prior to joining Phase Forward, Steve worked with GlaxoWellcome for 15 years as a Chartered Accountant, undertaking a number of senior finance and operational roles within the commercial and manufacturing areas of the generics division. Steve progressed to various global roles at GlaxoWellcome, from directing the group's worldwide manufacturing and supply strategy, through to the co-ordination of business development activities around the world. Before leaving Glaxo, Steve took over commercial responsibilities in the UK, running three of the five UK business units, and led business development.
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Industry Events |
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Small Scale Biomanufacturing – clinical trials, cell & gene therapies
18 September 2008, Clifton Pavilion, Bristol Zoo Gardens, Bristol
This one day conference, sponsored by bioProcessUK and organised by BioApproaches South West, will cover key, important topics relating to small scale GMP biomanufacturing.
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News and Press Releases |
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